Quality Engineer, CAPA Administrator

Description

The company makes an FDA-approved implantable device that reduces obstructive sleep apnea severity for people who cannot tolerate CPAP or do not get consistent benefit from it.

This role leads corrective and preventive action, manufacturing process improvements, quality system compliance and process monitoring, and works across Development, Manufacturing, Marketing, Information Systems and other Quality groups.

The job requires flexibility as priorities change and the ability to work without direct supervision.

Responsibilities

• Manage the CAPA process for internal CAPAs and for supplier corrective and preventive action requests (SCARs).
• Lead and coach cross-functional teams to resolve quality issues and move them through the CAPA process.
• Track CAPA deliverables and timelines, and analyze trends in CAPAs and SCARs.
• Schedule CAPA team meetings and monthly CAPA management reviews.
• Report CAPA progress at monthly CAPA meetings and at Quality management reviews.
• Support every stage of CAPA work: assigning owners, applying root cause tools such as 5 whys, Is/Is Not and Ishikawa, verifying effectiveness checks, and approving closure with Quality.
• Work with product quality and manufacturing teams on supplier corrective actions.
• Provide audit support for the CAPA and SCAR processes.
• Work with Material Quality to set SCAR timelines and process monitors.
• Support the nonconformance (NCR) process and trend nonconformance data.
• Help develop quality work instructions and procedure updates as assigned.
• File product and therapy field reports within required timelines, supply documents needed for investigations, and provide follow-up reports as needed.
• Complete required training and competency confirmations on time.
• Follow quality system procedures and policies, and suggest ways to improve processes continuously.

Requirements

• Bachelor's degree in a technical or scientific field.
• 2 to 5 years of experience in quality or design within the finished medical device industry.
• Working knowledge of ISO and FDA quality system requirements, such as ISO 13485, ISO 14969 and FDA 21 CFR Parts 820, 821 and 822.
• Demonstrated team leadership, with the ability to prioritize, execute and report on projects.
• Strong project and time management skills.
• Creative, effective problem solving and original thinking for compliance solutions.
• Ability to handle several tasks at once while priorities shift.
• Proficiency in MS Word, Excel and PowerPoint.
• Preferred: a bachelor's degree in an engineering discipline such as electrical, mechanical, materials, manufacturing or biomedical.
• Preferred: a master's degree in a technical or scientific field.
• Preferred: experience with Class III active implantables.
• Preferred: experience with the corrective action process, supplier corrective action requests, nonconformance resolution, field corrective actions and/or product recalls.
• Preferred: experience with ISO 14971 risk management and tools such as dFMEA and pFMEA.
• Preferred: ISO 13485 certified auditor or RAB auditor.
• Preferred: ASQ certifications such as CRE, CQM, CQE or CQA.

Conditions

On-site position.

Salary range: $70,000 to $90,000 USD, offered according to experience and qualifications. The range may change, and actual pay may vary based on location, experience, education and skill level.

Equal opportunity employer that focuses on building a diverse workforce.

Benefits

• Multiple health insurance plan options and employer contributions to a Health Savings Account.
• Dental, vision, life and disability coverage.
• 401k with employer match.
• Identity protection.
• Flexible time off.
• Tuition reimbursement.
• Employee assistance program.
• Equity awards and an Employee Stock Purchase Program open to employees at all levels.