Energy Jobline ZR
Senior Quality Manager in Durham
Energy Jobline ZR, Durham, North Carolina, United States, 27703
Senior Quality Manager
Full-time / Permanent
We are not currently working with third party agencies on this role.
About this Opportunity Hobson & Motzer is now part of Vantedge Medical. Vantedge Medical is the premier metals‑based med‑tech solutions partner from concept to full‑scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem‑solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe.
Vantedge Medical operates two manufacturing plants with primary operations—and headquarters—centrally located in Durham, CT; our Advanced Manufacturing Center is just a few miles away in Wallingford, CT.
This position will provide strategic and operational leadership for all Quality and Compliance activities at Hobson & Motzer’s Connecticut facilities, while supporting enterprise‑wide quality initiatives across other Vantedge Medical locations. This role ensures compliance with regulatory, customer, and internal quality standards—including ISO 9001, ISO 13485, and 21 CFR Part 820—and drives continuous improvement in all quality and manufacturing systems.
Responsibilities Oversee the Quality Control, Quality Engineering, and Quality Assurance functions supporting sustaining engineering, new product introduction (NPI), and continuous improvement initiatives.
Ensure quality engineering tools and methodologies (such as DFMEA, PFMEA, validation, and risk management) are effectively applied throughout the product lifecycle.
Leadership & Strategy
Lead, develop, and mentor the Quality and Compliance organization to meet company goals for safety, quality, delivery, and cost.
Define and implement quality strategies that align with corporate objectives and customer expectations.
Lead cross‑functional initiatives to support New Product Introductions (NPI) and continuous improvement.
Oversee departmental budgets, resource allocation, and capital planning to ensure operational effectiveness.
Champion employee engagement, team development, and succession planning to sustain a high‑performance culture.
Quality Management Systems (QMS)
Serve as the Management Representative for ISO 9001 and ISO 13485 Quality Management Systems.
Ensure QMS processes are implemented, documented, and maintained in compliance with applicable regulatory and customer requirements.
Lead management reviews, internal audits, and external audit readiness efforts.
Drive process standardization and documentation control in alignment with best practices and regulatory expectations.
Lead MRB activities and ensure timely closure of nonconformance, CAPA, and audit findings.
Compliance & Regulatory Oversight
Oversee compliance with all applicable standards and regulations, including ISO 13485.
Maintain systems for monitoring, auditing, and reporting on compliance performance.
Research and implement new or revised regulatory requirements and communicate updates across the organization.
Develop and manage compliance policies, risk assessments, and mitigation strategies.
Ensure periodic regulatory filings, records retention, and reporting obligations are met.
Customer & Supplier Quality
Serve as a primary contact for customers regarding quality issues, audits, and improvement initiatives.
Monitor and analyze customer feedback, complaints, and corrective actions to identify trends and implement preventive actions.
Oversee supplier qualification, audits, and corrective action processes to ensure supplier quality performance.
Maintain and review metrics such as cost of poor quality (COPQ) and total cost of quality (TCOQ).
Continuous Improvement & Technical Support
Lead continuous improvement and lean initiatives to optimize process capability and reduce waste.
Partner with production and engineering on PFMEA, process validation, and statistical process control (SPC).
Utilize data‑driven decision‑making to identify and resolve bottlenecks in inspection, calibration, and testing.
Ensure adherence to good documentation practices (GDP) and promote a culture of regulatory discipline.
Safety & Culture
Enforce and model the correct use of personal protective equipment (PPE) and compliance with job hazard analyses (JHAs).
Promote and sustain an organized, clean, and safe work environment through adherence to 6S standards.
Foster a culture of quality ownership and compliance awareness at all levels of the organization.
Supervisory Responsibilities Directly supervise Quality Assurance, Quality Control, and Compliance personnel. Conduct performance reviews, provide coaching, and support employee development through training and mentorship. Ensure the department is appropriately staffed, trained, and resourced to meet operational needs. Delegate authority, set expectations, and ensure accountability for results.
Requirements Education and Experience
Bachelor’s degree in Engineering, Quality Management, or related technical discipline (advanced degree considered).
Minimum of 8–10 years of progressively responsible experience in quality or compliance management within a regulated manufacturing environment (medical device experience).
Strong knowledge of ISO 13485, ISO 9001, and 21 CFR Part 820.
Certified Lead Auditor (ISO 9001 or ISO 13485).
Demonstrated expertise in PFMEA, process validation, and CAPA management.
Proven ability to lead cross‑functional teams, drive continuous improvement, and foster collaboration.
Exceptional analytical, communication, and leadership skills.
Proficiency in Microsoft Office and QMS software tools.
OSHA 30‑hour certification.
Travel: Minimal.
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We are not currently working with third party agencies on this role.
About this Opportunity Hobson & Motzer is now part of Vantedge Medical. Vantedge Medical is the premier metals‑based med‑tech solutions partner from concept to full‑scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem‑solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe.
Vantedge Medical operates two manufacturing plants with primary operations—and headquarters—centrally located in Durham, CT; our Advanced Manufacturing Center is just a few miles away in Wallingford, CT.
This position will provide strategic and operational leadership for all Quality and Compliance activities at Hobson & Motzer’s Connecticut facilities, while supporting enterprise‑wide quality initiatives across other Vantedge Medical locations. This role ensures compliance with regulatory, customer, and internal quality standards—including ISO 9001, ISO 13485, and 21 CFR Part 820—and drives continuous improvement in all quality and manufacturing systems.
Responsibilities Oversee the Quality Control, Quality Engineering, and Quality Assurance functions supporting sustaining engineering, new product introduction (NPI), and continuous improvement initiatives.
Ensure quality engineering tools and methodologies (such as DFMEA, PFMEA, validation, and risk management) are effectively applied throughout the product lifecycle.
Leadership & Strategy
Lead, develop, and mentor the Quality and Compliance organization to meet company goals for safety, quality, delivery, and cost.
Define and implement quality strategies that align with corporate objectives and customer expectations.
Lead cross‑functional initiatives to support New Product Introductions (NPI) and continuous improvement.
Oversee departmental budgets, resource allocation, and capital planning to ensure operational effectiveness.
Champion employee engagement, team development, and succession planning to sustain a high‑performance culture.
Quality Management Systems (QMS)
Serve as the Management Representative for ISO 9001 and ISO 13485 Quality Management Systems.
Ensure QMS processes are implemented, documented, and maintained in compliance with applicable regulatory and customer requirements.
Lead management reviews, internal audits, and external audit readiness efforts.
Drive process standardization and documentation control in alignment with best practices and regulatory expectations.
Lead MRB activities and ensure timely closure of nonconformance, CAPA, and audit findings.
Compliance & Regulatory Oversight
Oversee compliance with all applicable standards and regulations, including ISO 13485.
Maintain systems for monitoring, auditing, and reporting on compliance performance.
Research and implement new or revised regulatory requirements and communicate updates across the organization.
Develop and manage compliance policies, risk assessments, and mitigation strategies.
Ensure periodic regulatory filings, records retention, and reporting obligations are met.
Customer & Supplier Quality
Serve as a primary contact for customers regarding quality issues, audits, and improvement initiatives.
Monitor and analyze customer feedback, complaints, and corrective actions to identify trends and implement preventive actions.
Oversee supplier qualification, audits, and corrective action processes to ensure supplier quality performance.
Maintain and review metrics such as cost of poor quality (COPQ) and total cost of quality (TCOQ).
Continuous Improvement & Technical Support
Lead continuous improvement and lean initiatives to optimize process capability and reduce waste.
Partner with production and engineering on PFMEA, process validation, and statistical process control (SPC).
Utilize data‑driven decision‑making to identify and resolve bottlenecks in inspection, calibration, and testing.
Ensure adherence to good documentation practices (GDP) and promote a culture of regulatory discipline.
Safety & Culture
Enforce and model the correct use of personal protective equipment (PPE) and compliance with job hazard analyses (JHAs).
Promote and sustain an organized, clean, and safe work environment through adherence to 6S standards.
Foster a culture of quality ownership and compliance awareness at all levels of the organization.
Supervisory Responsibilities Directly supervise Quality Assurance, Quality Control, and Compliance personnel. Conduct performance reviews, provide coaching, and support employee development through training and mentorship. Ensure the department is appropriately staffed, trained, and resourced to meet operational needs. Delegate authority, set expectations, and ensure accountability for results.
Requirements Education and Experience
Bachelor’s degree in Engineering, Quality Management, or related technical discipline (advanced degree considered).
Minimum of 8–10 years of progressively responsible experience in quality or compliance management within a regulated manufacturing environment (medical device experience).
Strong knowledge of ISO 13485, ISO 9001, and 21 CFR Part 820.
Certified Lead Auditor (ISO 9001 or ISO 13485).
Demonstrated expertise in PFMEA, process validation, and CAPA management.
Proven ability to lead cross‑functional teams, drive continuous improvement, and foster collaboration.
Exceptional analytical, communication, and leadership skills.
Proficiency in Microsoft Office and QMS software tools.
OSHA 30‑hour certification.
Travel: Minimal.
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