Sr. Manager Quality Engineer

About the role

Manage the Supplier Quality Engineering group and Contract Manufacturing Quality in support of the manufacturing, development, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA, and other governmental regulations within Supplier Management processes and group.

Oversee all employee-related activities, including day-to-day resourcing, hiring, mentoring, and ongoing development of the staff. Partner with Procurement, R&D, Operations, Supply Chain, and Suppliers to ensure robust materials, products, processes, and systems while driving timely investigation, resolution, and prevention of supplier-related issues to minimize business disruptions.

Responsibilities

• Recommend changes to policies and establish procedures that affect the section or multiple disciplines.
• Monitor supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive resolution of supplier quality issues and risk control processes.
• Manage SCARs (Supplier Corrective Action Requests) resolution and implementation, including tracking SCAR age metrics.
• Oversee supplier audits and requalification processes.
• Manage the Incoming Inspection Team, process, and acceptance activities, including specifying and developing component acceptance criteria and test procedures for purchased subassemblies and components.
• Spearhead supplier-related non-conformances, including leading or participating in investigations.
• Analyze product/component failures, metrics, and deep failure analysis to advise on project management activities addressing failures and improving metrics.
• Develop, implement, and monitor various quality metrics, identifying opportunities for continuous improvement and customer satisfaction.
• Compile and represent data for quality process reviews, identifying issues, performance gaps, or component design improvements.
• Support project management activities for product, compliance, and quality projects.
• Ensure compliance with regulatory requirements, uphold the quality system, and support internal and external audits.
• Provide quality metric data to various functional groups within the organization.
• Actively promote and support the company’s management review process.
• Conduct supplier qualification audits for new suppliers by planning, conducting, reporting, and following up on supplier quality system audits.
• Drive and execute supplier quality agreements in collaboration with internal departments and suppliers.
• Oversee component qualification change projects in collaboration with key business partners and suppliers.
• Apply project management methodologies to plan, organize, and deliver results for supplier quality management (SQM) projects.
• Present supplier-related issues or opportunities to senior management.
• Train and mentor engineers, IQC Technicians, and other project team members on best practices in quality engineering and regulatory compliance.

Requirements

• BS in Engineering or related discipline and 8+ years of supplier quality experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry.
• 2+ years of supervisory experience strongly preferred.
• Experience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.).
• Strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485), risk management standards (ISO 14971), and good manufacturing practices.
• Experience in developing and validating test methods to comply with recognized standards.
• Lead auditor certification a plus.

Skills

• Excellent communication skills (both written and verbal).
• Ability to write clear, concise, and well-thought-out technical documentation.
• Strong attention to detail and ability to function in a fast-paced, dynamic environment.
• Effective communication with all organizational levels.

Benefits

• Comprehensive rewards package including stock options and bonus opportunities.
• Competitive salaries and a 401(k) plan.
• Health benefits.
• Generous paid time off and a parental leave program.

Pay

Salary Range: $190,000–$210,000. The salary range provided is a general guideline. When determining an offer, Imperative Care considers several factors, including the scope and responsibilities of the position, the candidate’s experience, education and training, key skills, internal equity, location, market conditions, and business needs.