Werfen North America
Job Summary
The Staff Quality Engineer works with cross-functional teams with the goal of ensuring and maintaining product safety and efficacy. The position uses technical knowledge and experience to ensure strategies for product and processes meet regulatory and business objectives. This role advises management on systems and techniques to maintain efficient and compliant systems. Responsibilities
Teamwork: Lead Quality Engineering on design and development projects, product and process changes, risk management, root cause investigations, validations, process capability, and trend analysis. Provide the team with strategic and tactical guidance related to Quality Management procedures for design and development, production, and post-production (post market) activities. Drive improvement projects and initiatives that reduce systemic manufacturing defects and improve quality systems. Independently lead multiple long-term projects. Interact with supervisor on activities, issues, or turning points. Model effective team dynamics behavior. Encourage and empower others to achieve project outcomes. Provide training and guidance to junior members of the team. Product and Process Life Cycle: Represent Quality Engineering in design and development activities through launch, product and process changes, sustaining on-market safety and efficacy, and post-market surveillance. Provide quality-consented subject matter expertise and ensure the delivery of objective evidence using scientific methodology that is technically valid, accurate, complete, and compliant with applicable regulations and standards in QMS areas such as product and process development, specification development, acceptance methods development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and nonconformance assessment. Risk Management: Maintain current knowledge of applicable risk management requirements and produce audit-ready Risk File documents. Coordinate evaluation of new and emerging risk standards. Assist in developing plans for meeting and complying with new risk regulations, guidances, and standards. Quality Science and Engineering: Perform independent quality review and evaluation of change orders, ensuring scientific approach, supporting evidence, technical validity, accuracy, and regulatory compliance. Guide identified gaps and remediation activities. Apply analytical thinking in investigations, root cause analysis, risk assessment evaluation, and CAPA development. Provide consensus Quality input into process investigations to ensure root causes and CAPAs are aligned. Collect and analyze defined quality metrics and data to identify issues or trends. Quality Engineering Strategic and Tactical Management: Assist management with development of strategic and tactical options to accomplish company goals. Implement assigned strategies and tactics. Manage Quality Engineering consultants when engaged. Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with regulations. Help design and document new and revised quality systems for product realization compliance. Maintain audit readiness of QMS processes and documentation. Escalate events impacting medical device safety or efficacy. Address nonconformances and take corrective and preventive actions. Support other functions in resolving quality system issues and concerns. Audit: Support internal and third-party audits, regulatory inspections preparation and execution. Assist in closing audit findings by guiding investigations and implementing corrections and corrective and preventive actions. Compliance: Ensure adherence to applicable SOPs, ISO, FDA and other Quality System regulations, as well as Environmental Health & Safety, Human Resources and related policies. Collaboration: Reflect Werfen and Inova values in quality work and relationships. Networking/Key relationships
Manufacturing Teams/Contract manufacturers/Suppliers R&D teams including Manufacturing Technical Support Other functions within the Quality and Regulatory organization Senior and Executive Management Affiliates Other Werfen Manufacturer’s Quality Engineering functions Professional and Technical Organizations Qualifications
Education
Bachelor’s degree in a life science, engineering, or equivalent required. Advanced degree preferred. Six Sigma/Lean Black Belt certification preferred. ASQ Certifications for Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), Risk Management Specialist or Quality Manager (CQM) preferred. Experience
Ten (10) or more years of work experience in IVD or medical device industry required Seven (7) years of work experience in Quality Engineering in the designated specialty of Process Quality Engineering, Supplier Quality Engineering, Design Quality Engineering for laboratory instruments (hardware and software), Design Quality Engineering for medical software, Design Quality Engineering for IVD assay reagents, Design Quality Engineering for IVD system integration, Risk Quality Engineering, or related functions. Project management experience preferred. Skills & Capabilities
Advanced knowledge of current compliance requirements (e.g., US QSRs, EU IVDR, ISO 13485, ISO 14971, ISO 17025, IEC 60825) and ability to interpret and apply quality requirements. Advanced knowledge in design controls, risk assessment, root cause investigations, trend analysis, statistical sampling, change control, nonconformance assessment, design of experiments, project management, data mining, requirements analysis, and traceability. Advanced knowledge of hardware and software engineering principles for IVD systems; familiarity with diagnostic platforms and systems integration, including validation/verification processes. Working knowledge of fluidics in diagnostic devices and how it applies to operation and integration of fluidic systems. Mentoring and technical development of junior staff. Ability to work effectively in ambiguity and manage multiple tasks as a team member or individual contributor. Strong influencing and negotiation skills and ability to build collaborative relationships. Creative problem-solving approaches and strong verbal/written communication, including technical writing. Proficiency in Microsoft Office Suite and related tools. Travel Requirements
If required, provide approximate percentage of travelling time. Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is regularly required to communicate, detect, identify, and inspect data. The role may require standing or walking up to 8 hours per day or sitting up to 8 hours per day. Must be able to use hands for keyboard, pipettes, and lab equipment. May involve reaching, climbing stairs, bending, kneeling, or crouching. Vision requirements include close, distance, color, peripheral, depth perception, and adjustment of focus. May occasionally lift up to 25 pounds. The noise level is usually moderate, and the role is active with varying mobility. The salary range for this position is currently $150,000 - $180,000. Compensation is based on qualifications, experience, skills, education, certifications, internal equity, and organizational needs. If you are interested in constant learning and daily challenges, please submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen prohibits unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by law. If you require an accommodation in relation to the online application process, please contact talentacquisition@werfen.com for assistance. We operate in over 30 countries and in more than 100 territories through distributors, with annual revenue around $2 billion and more than 7,000 employees worldwide. www.werfen.com
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The Staff Quality Engineer works with cross-functional teams with the goal of ensuring and maintaining product safety and efficacy. The position uses technical knowledge and experience to ensure strategies for product and processes meet regulatory and business objectives. This role advises management on systems and techniques to maintain efficient and compliant systems. Responsibilities
Teamwork: Lead Quality Engineering on design and development projects, product and process changes, risk management, root cause investigations, validations, process capability, and trend analysis. Provide the team with strategic and tactical guidance related to Quality Management procedures for design and development, production, and post-production (post market) activities. Drive improvement projects and initiatives that reduce systemic manufacturing defects and improve quality systems. Independently lead multiple long-term projects. Interact with supervisor on activities, issues, or turning points. Model effective team dynamics behavior. Encourage and empower others to achieve project outcomes. Provide training and guidance to junior members of the team. Product and Process Life Cycle: Represent Quality Engineering in design and development activities through launch, product and process changes, sustaining on-market safety and efficacy, and post-market surveillance. Provide quality-consented subject matter expertise and ensure the delivery of objective evidence using scientific methodology that is technically valid, accurate, complete, and compliant with applicable regulations and standards in QMS areas such as product and process development, specification development, acceptance methods development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and nonconformance assessment. Risk Management: Maintain current knowledge of applicable risk management requirements and produce audit-ready Risk File documents. Coordinate evaluation of new and emerging risk standards. Assist in developing plans for meeting and complying with new risk regulations, guidances, and standards. Quality Science and Engineering: Perform independent quality review and evaluation of change orders, ensuring scientific approach, supporting evidence, technical validity, accuracy, and regulatory compliance. Guide identified gaps and remediation activities. Apply analytical thinking in investigations, root cause analysis, risk assessment evaluation, and CAPA development. Provide consensus Quality input into process investigations to ensure root causes and CAPAs are aligned. Collect and analyze defined quality metrics and data to identify issues or trends. Quality Engineering Strategic and Tactical Management: Assist management with development of strategic and tactical options to accomplish company goals. Implement assigned strategies and tactics. Manage Quality Engineering consultants when engaged. Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with regulations. Help design and document new and revised quality systems for product realization compliance. Maintain audit readiness of QMS processes and documentation. Escalate events impacting medical device safety or efficacy. Address nonconformances and take corrective and preventive actions. Support other functions in resolving quality system issues and concerns. Audit: Support internal and third-party audits, regulatory inspections preparation and execution. Assist in closing audit findings by guiding investigations and implementing corrections and corrective and preventive actions. Compliance: Ensure adherence to applicable SOPs, ISO, FDA and other Quality System regulations, as well as Environmental Health & Safety, Human Resources and related policies. Collaboration: Reflect Werfen and Inova values in quality work and relationships. Networking/Key relationships
Manufacturing Teams/Contract manufacturers/Suppliers R&D teams including Manufacturing Technical Support Other functions within the Quality and Regulatory organization Senior and Executive Management Affiliates Other Werfen Manufacturer’s Quality Engineering functions Professional and Technical Organizations Qualifications
Education
Bachelor’s degree in a life science, engineering, or equivalent required. Advanced degree preferred. Six Sigma/Lean Black Belt certification preferred. ASQ Certifications for Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), Risk Management Specialist or Quality Manager (CQM) preferred. Experience
Ten (10) or more years of work experience in IVD or medical device industry required Seven (7) years of work experience in Quality Engineering in the designated specialty of Process Quality Engineering, Supplier Quality Engineering, Design Quality Engineering for laboratory instruments (hardware and software), Design Quality Engineering for medical software, Design Quality Engineering for IVD assay reagents, Design Quality Engineering for IVD system integration, Risk Quality Engineering, or related functions. Project management experience preferred. Skills & Capabilities
Advanced knowledge of current compliance requirements (e.g., US QSRs, EU IVDR, ISO 13485, ISO 14971, ISO 17025, IEC 60825) and ability to interpret and apply quality requirements. Advanced knowledge in design controls, risk assessment, root cause investigations, trend analysis, statistical sampling, change control, nonconformance assessment, design of experiments, project management, data mining, requirements analysis, and traceability. Advanced knowledge of hardware and software engineering principles for IVD systems; familiarity with diagnostic platforms and systems integration, including validation/verification processes. Working knowledge of fluidics in diagnostic devices and how it applies to operation and integration of fluidic systems. Mentoring and technical development of junior staff. Ability to work effectively in ambiguity and manage multiple tasks as a team member or individual contributor. Strong influencing and negotiation skills and ability to build collaborative relationships. Creative problem-solving approaches and strong verbal/written communication, including technical writing. Proficiency in Microsoft Office Suite and related tools. Travel Requirements
If required, provide approximate percentage of travelling time. Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is regularly required to communicate, detect, identify, and inspect data. The role may require standing or walking up to 8 hours per day or sitting up to 8 hours per day. Must be able to use hands for keyboard, pipettes, and lab equipment. May involve reaching, climbing stairs, bending, kneeling, or crouching. Vision requirements include close, distance, color, peripheral, depth perception, and adjustment of focus. May occasionally lift up to 25 pounds. The noise level is usually moderate, and the role is active with varying mobility. The salary range for this position is currently $150,000 - $180,000. Compensation is based on qualifications, experience, skills, education, certifications, internal equity, and organizational needs. If you are interested in constant learning and daily challenges, please submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen prohibits unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by law. If you require an accommodation in relation to the online application process, please contact talentacquisition@werfen.com for assistance. We operate in over 30 countries and in more than 100 territories through distributors, with annual revenue around $2 billion and more than 7,000 employees worldwide. www.werfen.com
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