Ascential Technologies
Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. We are looking for a Quality Engineering Manager to join our multidisciplinary team, contributing to cutting-edge projects that drive innovation in healthcare and diagnostics.
POSITION SUMMARY:
The Quality Engineering Manager leads the Quality Engineering team and function, playing a critical role in ensuring that the company's products consistently meet quality standards and regulatory requirements throughout the entire product lifecycle. This position focuses on implementing and managing quality engineering principles related to design controls, risk management, process validation, supplier quality, statistical analysis, and continuous improvement to ensure product safety, efficacy, and compliance with FDA QSR (21 CFR 820), ISO 13485, ISO 9001, and other applicable regulations.
ESSENTIAL FUNCTIONS:
Team Leadership & Development:
Education & Experience:
Manages personnel and monitors operations of a unit or sub-unit. Works on issues of broad scope and complexity, and uses judgement to analyze situations based on data and relevant facts. Requires full knowledge of own area of functional responsibility. Establishes policies and procedures with potential impact to other areas of the organization.
Supervision:
Provides direct supervision to a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules. A portion of time is normally spent performing individual tasks related to the unit or sub-unit. Generally may supervise semi-skilled and skilled personnel.
Normally receives little instruction on day-to-day work; independently manages the coordination of activities of a section or department with responsibility for resources, methods, and results.
Responsible for a high level of internal and external partnerships and for interacting in a manner which reflects positively on the department and is consistent with the company’s policies and core values.
Knowledge, Skills & Abilities:
EFFORT REQUIRED:
Physical Activities :
On a continuous basis, sit at desk for a long period of time; write or use a keyboard to communicate through written means. Intermittently answer telephone. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
TRAVEL:
This position may require limited travel.
This is an on-site position in San Diego with an annual salary range of $132,000 - $165, 000, based on experience and qualifications
Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
POSITION SUMMARY:
The Quality Engineering Manager leads the Quality Engineering team and function, playing a critical role in ensuring that the company's products consistently meet quality standards and regulatory requirements throughout the entire product lifecycle. This position focuses on implementing and managing quality engineering principles related to design controls, risk management, process validation, supplier quality, statistical analysis, and continuous improvement to ensure product safety, efficacy, and compliance with FDA QSR (21 CFR 820), ISO 13485, ISO 9001, and other applicable regulations.
ESSENTIAL FUNCTIONS:
Team Leadership & Development:
- Lead, manage, mentor, and develop a team of Quality Engineers.
- Establish clear goals, objectives, and performance standards for the QE team aligned with overall quality and business objectives.
- Allocate QE resources effectively to support new product development, sustaining engineering, manufacturing operations, and supplier quality activities.
- Foster a culture of quality and continuous improvement within the QE team and across collaborating departments.
- Provide Quality Engineering leadership and oversight for design and development projects according to established Design Control procedures.
- Ensure robust translation of user needs into design inputs, verification & validation (V&V) activities, and design transfer to manufacturing, line transfers.
- Oversee the development and maintenance of Design History Files (DHFs).
- Collaborate closely with R&D and Product Development teams.
- Oversee the implementation and maintenance of the company's risk management process in accordance with ISO 14971.
- Ensure comprehensive risk management activities (e.g., Hazard Analysis, FMEAs - Design & Process) are conducted throughout the product lifecycle.
- Manage and maintain Risk Management Files (RMFs).
- Develop and manage strategies for process validation (IQ/OQ/PQ) for manufacturing processes, equipment, test methods, and software used in production and quality systems.
- Review and approve validation protocols and reports.
- Oversee the application of statistical methods (e.g., SPC, capability analysis) for monitoring and controlling manufacturing processes.
- Provide QE oversight for supplier evaluation, qualification, auditing, and performance monitoring.
- Manage the Supplier Corrective Action Request (SCAR) process from a technical QE perspective.
- Collaborate with Supply Chain/Procurement to ensure supplier quality requirements are met.
- Lead or support complex root cause investigations for Corrective and Preventive Actions (CAPAs), non-conformances, and audit findings.
- Ensure the effectiveness of implemented corrective and preventive actions.
- Analyze quality data (e.g., complaints, non-conformances, yield) to identify trends and drive continuous improvement initiatives using methodologies like Lean or Six Sigma.
- Ensure QE activities and documentation comply with FDA regulations (21 CFR 820), ISO 13485, ISO 9001, and other relevant international standards (e.g., EU MDR, MDSAP requirements where applicable).
- Contribute to the development, implementation, and improvement of the Quality Management System (QMS).
- Support internal and external audits (e.g., FDA, Notified Body) as a subject matter expert for QE areas.
- Lead or provide significant Quality Engineering support for manufacturing process transfers between facilities or from internal sites (including overseas locations).
- Develop and execute QE strategies for transfers, including defining transfer criteria, comparability protocols, risk assessments, and validation requirements for the receiving site.
- Ensure quality standards and process capabilities are maintained or improved post-transfer. Collaborate closely with Manufacturing Engineering, Operations, and Supply Chain during transfers.
Education & Experience:
- Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Industrial, Electrical) or a closely related technical/scientific field. Advanced degree (Master's) in Engineering or a related field preferred.
- Minimum of 7-10 years of progressive experience in Quality Engineering within the life science industry.
- Minimum of 3-5 years of direct management or supervisory experience leading engineers or technical staff.
- Relevant professional certifications (e.g., ASQ CQE, CRE, CMQ/OE).
- Six Sigma Green Belt or Black Belt certification.
- Experience directly managing QE responsibilities during regulatory inspections and audits (FDA, Notified Body).
- Experience with wide range of life science products and technologies (e.g., instruments, disposables, IVDs).
Manages personnel and monitors operations of a unit or sub-unit. Works on issues of broad scope and complexity, and uses judgement to analyze situations based on data and relevant facts. Requires full knowledge of own area of functional responsibility. Establishes policies and procedures with potential impact to other areas of the organization.
Supervision:
Provides direct supervision to a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules. A portion of time is normally spent performing individual tasks related to the unit or sub-unit. Generally may supervise semi-skilled and skilled personnel.
Normally receives little instruction on day-to-day work; independently manages the coordination of activities of a section or department with responsibility for resources, methods, and results.
Responsible for a high level of internal and external partnerships and for interacting in a manner which reflects positively on the department and is consistent with the company’s policies and core values.
Knowledge, Skills & Abilities:
- Proven leadership, team building, and personnel management capabilities.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent project management and organizational skills.
- Exceptional written and verbal communication and interpersonal skills.
- Ability to effectively collaborate and influence cross-functional teams.
- Expert knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 9001.
- Expert knowledge of Risk Management standard ISO 14971.
- Strong working knowledge of Design Controls, Process Validation (IQ/OQ/PQ), Statistical Process Control (SPC), CAPA systems, and Supplier Quality Management.
- Familiarity with relevant standards (e.g., IEC 60601, IEC 62304, etc.) may be required depending on the product.
- Proficiency in applying statistical techniques and using statistical software (e.g., Minitab).
EFFORT REQUIRED:
Physical Activities :
On a continuous basis, sit at desk for a long period of time; write or use a keyboard to communicate through written means. Intermittently answer telephone. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
TRAVEL:
This position may require limited travel.
This is an on-site position in San Diego with an annual salary range of $132,000 - $165, 000, based on experience and qualifications
Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.