Quality Engineer (Medical Device)

Spirair, a venture capital backed medical device company, was co-founded by two Stanford Biodesign and Innovation fellows with a shared interest in optimizing outcomes and patient experience through innovation solutions. With a passion for developing elegant technologies that evolve care and enhance accessibility and effectiveness, the Spirair team is partnering with leading ENT advisors and industry veterans to offer treatment options that are both massively impactful and minimally invasive.

We are looking for a Quality Engineer who will assure Spirair’s quality system and processes are in compliance with U.S. medical device regulations and applicable regulatory standards.  This position is responsible for managing day-to-day Quality operation activities including supplier controls, incoming inspection, equipment management, nonconforming materials, complaint handling system, and quality manufacturing support.  This position will ensure compliance with applicable regulatory requirements and company policies by supporting product quality, investigating complaints, managing equipment and process controls, participating in design controls, and assisting with Quality System activities.

This position will require working in both our Mountain View and South San Francisco offices. Only local candidates will be considered.

MAJOR DUTIES AND RESPONSIBILITIES:

• Product Quality: Provide incoming inspection support, review of lot history documentation, and product release. Head Material Review Board activities for nonconforming material and drive resolution and closure of NCMRs.  Approve and monitor supplier performance and perform supplier audits, as required.
• Complaint System: Lead complaint investigations and reporting. Track returned materials, investigate returned and unreturned product. Use root cause analysis tools and methodology. Initiate, complete and close complaint reports.  Identify and recommend corrective actions for product issues, as identified.   Coordinate the identification, assignment, monitoring, and completion of product improvement projects based on manufacturing experience, supplier, or process related studies.  Solve moderately complex problems at the system level.
• Equipment and Process Controls: Review/approve inspection and manufacturing equipment creation and release. Track equipment calibration and preventive maintenance schedules and coordinate calibration. Function as key Quality contact for internal cleanroom and manufacturing, as well as contract manufacturer, including on-site support and troubleshooting as needed. Assist on manufacturing line and investigate issues.  Perform process validations, write protocols and reports and assist in development of test methodology and fixturing.
• Design Controls: Participate in design control activities including risk management, test protocol development, design control meetings, and quality plans.
• Continuous Improvement: Participate in investigation and closure of CAPAs.  Compile and report on relevant quality metrics, including monthly dashboard and management review meetings.
• QMS Support: Assist with Document Control initiation, routing, approval and release of documents.  Assist with training compliance for company. Assist with maintenance of eQMS system.
• Serve as Quality Assurance representative on operations / manufacturing activities.
• As needed, conduct testing utilizing DOE methodology and other experimental design tools.  Generate complex written reports.
• Assist with continued development of company’s standard operating procedures.
• Maintain a professional, credible image with regulatory agencies, key physicians, consultants, vendors, and co-workers.
• Perform other duties as assigned.

PREFERRED QUALIFICATIONS:

Education and/or Job Experience: 

• Bachelor’s degree in Engineering or Life Sciences or equivalent.  Master’s degree preferred.
• 5+ years experience in medical device manufacturing/quality control field.
• Experience in implementation and maintenance of Quality Management System for medical device companies.
• Experience with eQMS systems (e.g., Arena).

Skills, Abilities, and Requirements: 

• In depth knowledge of current FDA Quality System Regulation and Quality Management System Regulation.
• Excellent communication, interpersonal and organizational skills.
• Ability to collaborate in a team environment as well as work independently.
• Self-starter with the ability to manage multiple projects in a dynamic environment.
• Strong analytical and problem-solving skills.
• Strong communication skills, verbal and written.
• Proficient in Microsoft Word/Excel/PowerPoint.

Spirair offers highly competitive salaries, equity, and benefits, including medical, dental, and vision insurance, paid time off, and 401(k). Legal authorization to work in the US is required. We are not able to sponsor individuals for employment visas for this job. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment verification form upon hire.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

The expected base salary range for this role is $115,000 - $150,000. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. This position will require working in both our Mountain View and South San Francisco offices. Only local candidates will be considered.