Sr. Manager Quality Engineer

Imperative Care; Campbell (CA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Stock options

Bonus opportunities

401(k) plan

Health benefits

Paid time off

Parental leave

Job summary

Imperative Care is seeking a Senior Supplier Quality Manager to lead the Supplier Quality Engineering and Contract Manufacturing Quality groups. You will ensure compliance with ISO 13485, FDA regulations, and governing standards while directing supplier collaboration and auditable processes.

The role requires 8+ years in supplier quality within medical devices, supervisory experience, and strong documentation/communication skills.

Qualifications

• BS in Engineering or related discipline with 8+ years in supplier quality, or MS with 6+ years in medical device or regulated industry.
• 2+ years supervisory experience strongly preferred.
• Experience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.).
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP.
• Excellent written and verbal communication skills; ability to produce clear technical docs.
• Lead auditor certification a plus.

Responsibilities

• Lead and manage Supplier Quality Engineering and Contract Manufacturing Quality in support of manufacturing, development, and distribution of medical devices.
• Direct collaboration with suppliers/CMs/OEMs and business partners to ensure robust materials, products, processes, and systems.
• Oversee staffing, mentoring, and development of the supplier quality team.
• Drive improvements in supplier quality through metrics, audits, and CAPA management.
• Investigate supplier-related issues with timely resolution/prevention to minimize disruptions.
• Monitor SCARs and drive resolution and risk control processes.
• Oversee supplier audits/requalification and incoming inspection criteria for subassemblies.
• Promote regulatory compliance and support internal/external audits.
• Present supplier-related issues or opportunities to senior management.
• Lead projects applying PM methodologies to SQM initiatives.

Skills

Supplier Quality Management

Quality System Compliance

CAPAs NCRs SCARs

Audits

Project Management

Risk Management

Communication

Lead Auditor

Education

Bachelor's in Engineering

MS in Engineering (optional)

Tools

None

Job description

SUMMARY

Manage 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.

• Manage and direct the collaboration with suppliers/CMs/OEMs and business partners to ensure robust materials, products, processes, and systems.


• Manage all employee related activities, including day-to-day resourcing, hiring, mentoring and on-going development of the staff.


• Recommends changes to policies and establishes procedures that affect section or multiple disciplines.


• Partner with Procurement, R&D, Operations, Supply Chain and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.


• Monitor the analysis of supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.


• Monitor and manage SCARs resolution and implementation of each SCAR, managing the SCAR age metric.


• Managing supplier Audits/requalification process.


• Managing the Incoming Inspection Team, process, oversee incoming inspection acceptance activities, offering direction to specify and develop component acceptance criteria/test procedures for purchased subassemblies and components.


• Spearhead and supplier related non-conformances, including leading/participating in investigations.


• Analyse product/components failures, metrics and deep failure analysis to offer advice in project management activities that address said failures and metrics improvement.


• Develop, implement and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for quality process reviews identifying issues/performance, or component design improvement activities.


• Help in project management activities for a series of product, compliance and quality projects


• Ensure compliance to regulatory requirements. Uphold quality system. 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 supplier (when is required) by planning, conducting, reporting, and follow-up on supplier quality system audits.


• Drive and execute supplier quality agreements by working with different department within ICI and the suppliers.


• Oversee the component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.


• Apply Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for supplier quality management (SQM) projects.


• Responsible for presenting supplier-related issues or opportunities to next management level.


• Manage all departmental employee related activities, including the day-to-day resourcing, hiring, mentoring, and on-going development to the staff.


• Manage, Train and mentor engineers, IQC Technicians and other project team members on best practices in quality engineering and regulatory compliance to external standards.

EDUCATION/EXPERIENCE

• 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 industryLead development and validation of test methods to comply with recognized standards


• 2+ years of supervisory experience strongly preferred


• Experience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.)


• Must have strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485), risk management standards (ISO 14971), and good manufacturing practices.


• Excellent communications skills (both written and verbal)


• Must be able to write clear, concise, and well thought out technical documentation.


• Ability to communicate effectively, both orally and in writing, with all organizational levels


• Strong attention to detail and ability to function in a fast-paced dynamic environment.


• Lead auditor certification a plus

At Imperative Care, employees share in our collective success through a comprehensive rewards package that includes stock options, bonus opportunities, competitive salaries, a 401(k) plan, health benefits, generous paid time off, and a parental leave program.
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.

Join us and help shape the future of stroke care.