QMS Engineer

QMS Engineer

The QMS Engineer will lead and support the assessment, remediation, and integration of an acquired medical device company's Quality Management System. This role focuses on conducting comprehensive ISO quality system gap assessments, identifying compliance deficiencies, and driving corrective and preventive actions to achieve and maintain compliance with applicable regulatory and quality requirements. The QMS Engineer will collaborate closely with cross-functional teams across Regulatory Affairs, Operations, Engineering, Manufacturing, Supply Chain, and Quality to harmonize processes and strengthen the overall quality system.

Responsibilities

• Lead and execute a comprehensive ISO quality system gap assessment of an acquired medical device company's Quality Management System.

• Review and assess quality procedures, records, processes, and documentation to determine compliance with ISO standards and applicable regulatory requirements.

• Identify quality system gaps, compliance risks, and process deficiencies, document findings, and recommend appropriate corrective and preventive actions.

• Develop and implement remediation plans to address identified gaps and achieve compliance with ISO standards, FDA Quality System Regulation (21 CFR Part 820), MDSAP, and other relevant regulations.

• Author, revise, and implement quality procedures, work instructions, forms, and quality records to ensure robust and compliant documentation.

• Lead and support Corrective and Preventive Action (CAPA) activities, including root cause investigations, corrective action planning, and effectiveness verification.

• Partner with cross-functional teams including Engineering, Operations, Manufacturing, Regulatory Affairs, Supply Chain, and Quality to implement quality system improvements and integration activities.

• Support the integration and harmonization of the acquired company's quality processes into the broader corporate quality system.

• Plan, conduct, and support internal quality audits and participate in supplier, customer, certification, and regulatory audits.

• Drive remediation activities, provide clear status updates to management, and ensure timely closure of identified quality system deficiencies.

• Facilitate risk assessments and ensure alignment with applicable risk management requirements and standards.

• Develop and deliver training on quality system requirements, revised procedures, and compliance expectations to relevant stakeholders.

• Support inspection readiness activities and contribute to responses to audit observations and regulatory findings.

• Drive continuous improvement initiatives to enhance quality system effectiveness, operational excellence, and overall compliance.

Essential Skills

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, Life Sciences, or a related technical discipline.

• Minimum of 35 years of Quality Engineering experience in the medical device industry.

• Demonstrated experience with ISO-based Quality Management Systems and medical device regulatory requirements.

• Proven experience developing and implementing quality system remediation plans and corrective actions.

• Strong knowledge of FDA Quality System Regulation (QSR) 21 CFR Part 820, CAPA processes, document control, nonconformance management, and risk management.

• Experience authoring and revising quality system procedures and controlled documents.

• Strong analytical and problem-solving skills, including root cause investigation capabilities.

• Excellent written and verbal communication skills, with the ability to clearly present complex quality and regulatory concepts.

• Ability to work independently and lead cross-functional projects in a regulated medical device environment.

• Proficiency with Microsoft Office applications and experience using electronic Quality Management Systems (eQMS).

Additional Skills & Qualifications

• Experience conducting quality system audits, compliance assessments, and ISO gap analyses.

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification.

• ISO Lead Auditor certification.

• Experience supporting mergers, acquisitions, or quality system integration projects within the medical device industry.

• Experience with FDA inspections, ISO certification audits, and MDSAP audits.

• Knowledge of EU MDR requirements, ISO-based risk management standards, and design control requirements for medical devices.

• Experience working with Class II and/or Class III medical devices.

• Project management experience leading complex quality and compliance initiatives.

• Experience implementing or enhancing electronic Quality Management Systems (eQMS).

• Strong change management and stakeholder engagement skills, with the ability to influence and align cross-functional teams.

• Master's degree in Engineering, Quality, Regulatory Affairs, or a related field is preferred.

Work Environment

This role operates within a regulated medical device environment focused on maintaining robust quality and regulatory compliance. The QMS Engineer will collaborate closely with cross-functional teams across Engineering, Operations, Manufacturing, Regulatory Affairs, Supply Chain, and Quality, often working on complex integration and remediation projects. Work typically involves a combination of office-based activities, such as documentation development, data analysis, and use of Microsoft Office and electronic Quality Management Systems (eQMS), along with participation in audits, inspections, and cross-functional meetings. The culture emphasizes continuous improvement, operational excellence, and strong adherence to quality standards, offering opportunities to lead impactful initiatives that directly support patient safety and regulatory compliance.

Job Type & Location

This is a Contract position based out of Fremont, CA.

Pay and Benefits

The pay range for this position is $62.50 - $62.50/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Fremont,CA.

Application Deadline

This position is anticipated to close on Oct 9, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.