Quality Engineering Manager

Cambridge Recruiters; San Diego (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Cambridge Recruiters is seeking a hands-on Quality Engineering Manager for a 80-person medical devices company delivering drug/device combination products with US approval and CE mark. You will lead a small QE team and work closely with suppliers to ensure compliance and product quality.

The role emphasizes quality leadership, problem solving, and process validation across IQ/OQ/PQ, risk management, and regulatory alignment with ISO 14971.

Qualifications

• Minimum 5-7 years medical device experience in ISO/cGMP environments.
• 2-4+ years people management at a manager level or above.
• Experience with catheters and/or medical devices; interventional cardiology products helpful.
• Proven validation and compliance of regulated products; e-beam sterilization and software validation preferred.
• Experience with regulatory requirements for component and product testing (ASTM, ISO, ICH).

Responsibilities

• Provide direct management and technical support to Quality Engineers engaged in compliance, risk remediation, and cost reduction initiatives.
• Mentor and coach QEs; develop personnel and succession planning.
• Provide quality leadership, oversight, and direction in problem-solving and team-building activities.
• Support new product development and maintenance with QEs to ensure ISO-compliant designs and verifications.
• Develop and execute IQ/OQ/PQ protocols, validations, gauge studies, calibration procedures.
• Lead risk management activities for products under design authority per ISO 14971; ensure regulatory readiness.
• Review and approve controlled documents (WIs, specs, procedures, validation reports).
• Maintain a structure that delivers excellent customer service and optimal resource use.

Skills

Statistical methods

Six Sigma

DOE

Risk management

Root cause analysis

Communication skills

Training others

Job description

Quality Engineering Manager - Medical Devices (Drug/Device Combination Product)

80-Person company, well-funded company

Product has US Approval & CE Mark

Looking for very hands-on Manager of Quality Engineering (working manager), and will manage a small team (QE & Technician).

Duties / Responsibilities:

• Manager - Quality Engineering provides direct management and technical support to the Quality Engineers supporting business needs, including compliance, risk remediation, new product development, and cost reduction efforts linked to operational effectiveness
• Provide support/ mentoring/ coaching of QEs for application of technical principles, theories, concepts and quality, tools and systems; develop personnel, including dedicated succession planning and contingency management focused on win-win situations
• The position shall provide quality engineering leadership, oversight, and direction in problem-solving and team-building capabilities.
• The position shall support new product development and product maintenance through the application of Quality engineering skills for medical devices, assuring that products are designed utilizing systems which comply with applicable quality standards, industry and government standards/regulations and ultimately conform to customer expectations for safety and effectiveness.
• Develop and ensure the execution of process/equipment IQ/OQ/PQ protocols and reports. Conduct test method qualifications and validations. Develop gauge reliability and repeatability studies for test and production-related equipment. Develop equipment calibration procedures.
• Develop sampling plans for incoming materials and in-process and finished product testing based on appropriate statistical methods.
• Responsible for product-related investigations and corrective actions. Maintain a working relationship with suppliers to ensure resolution of supplier-critical issues and investigations. This may include supplier visits to technically assist in the resolution of issues and investigations. Ensure that all corrective/preventive measures meet acceptable reliability standards, and that documentation is compliant with requirements. Assure that the policies, procedures, and systems are designed and implemented to develop products which conform to established
• Lead execution of Quality activities required to meet established Business Goals and quality metric targets for product platforms and/or processes.
• Develops technical solutions and program management to address complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity
• Product expert that ensures customer requirements are met
• Assumes a leadership role in continuous improvement and development of strategies to improve Quality
• As part of the quality organization, reviews and approves assigned controlled documents (e.g. work instructions, quality specifications, engineering specifications, procedures and validations protocols/reports).
• Establish and maintain a team structure that provides excellent customer service and enables optimal use of resources
• Provide required input for Management Review
• Provide the required Quality Engineering support and promote use of statistical tools in product design and development activities
• Lead Risk Management activities for products under design authority in compliance with ISO 14971
• Provide feedback to prepare budget and adhere to approved departmental budget
• Participates in, and may provide leadership for multi-disciplinary projects
• Participate in customer product complaint analyses, evaluation and investigation. Perform investigational activities including evaluation of returned products and complaint trending analysis.
• In conjunction with product development, participates in the updating, maintaining, and approving of risk analysis/risk management documentation.
• Participates in internal/supplier audits and interact with external regulatory inspectors as subject matter expert.
• Participates in and manages special projects and other duties as assigned.

Education and/or Experience

• Minimum of 5-7 years medical device experience or similarly regulated ISO or cGMP/GLP environment is required.
• 2-4+ years People Management experience (Manager level or above)
• Previous experience with catheters and/or medical devices is required. Interventional cardiology products experience is helpful.
• Proven record of validation and compliance of regulated products is required. E-beam sterilization validation and software validation experience is preferred.
• Experience with regulatory requirements and guidance for component and product testing including ASTM, ISO and ICH.

Required Knowledge/Skills

• Strong statistical background and practical application of statistical techniques - Six Sigma, DOE, etc.
• Demonstrated problem solving and root cause analysis skills using risk-based approach
• ASQ certification (QE, and/or Auditor) preferred
• Strong attention to detail and accuracy
• Ability to train others, work independently or in team setting required.
• Effective presentation/communication skills, prioritization and resource management skills.

Local Candidates strongly preferred, however some assistance may be offered for well-qualified candidates from out of the area.

No H1B or Visa Sponsorships - must have US Work Authorization or be US Citizen

No C2C (Corp to Corp) candidates will be considered