Quality Engineer, CAPA Administrator

Regulatory Jobs; Golden Valley (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401k with match

Tuition reimbursement

Employee assistance program

Job summary

Inspire Medical Systems seeks a CAPA and Quality Systems specialist to lead corrective and preventive action efforts across internal and supplier actions. You’ll partner with development, manufacturing, marketing and quality teams to ensure adherence to ISO 13485 and FDA quality system requirements, monitor CAPA timelines, and drive continual improvement.

Ideal candidates have 2–5 years in medical device quality or design, strong leadership, and proficiency with MS Word, Excel and PowerPoint.

Qualifications

• Bachelor’s degree in a technical or scientific field.
• Preferred engineering discipline (electrical, mechanical, materials, manufacturing or biomedical).
• 2–5 years minimum experience in quality or design in finished medical device industry.
• Knowledge of ISO and FDA/Quality System requirements.
• Strong project and time management skills; problem solving for compliance.

Responsibilities

• Manage CAPA process for internal Inspire CAPAs and supplier SCARs.
• Lead cross-functional teams to resolve quality issues and CAPA
• Monitor CAPA deliverables, timelines and trends for CAPAs/SCARs
• Schedule CAPA team meetings and monthly CAPA reviews
• Report CAPA progress at monthly meetings and quality reviews
• Support CAPA activity including root-cause analysis and verification
• Partner with product quality and manufacturing teams on supplier actions
• Provide audit support for CAPA and SCAR processes
• Collaborate with Material Quality to develop SCAR timelines
• Support non-conformance processes and process trending
• Assist in developing quality work instructions and updates

Skills

CAPA management

Quality systems

Regulatory compliance

Project leadership

MS Office

Problem solving

Education

Bachelor’s degree in technical or scientific field

Bachelor’s degree in engineering

Master’s degree in technical field

Tools

Quality management systems

Job description

ABOUT INSPIRE MEDICAL SYSTEMS

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!

POSITION SUMMARY

This position must provide expertise and leadership in the area of corrective and preventive action, manufacturing process improvements, quality system requirements and process monitoring. This position will work with Development, Manufacturing, Marketing, Information Systems and other Quality functional areas to ensure work is completed in accordance with Inspire procedures and geographic regulations. This role must be flexible for changing priorities and able to work without direct supervision.

MAIN DUTIES/RESPONSIBILITIES

• Manage corrective and preventive action (CAPA) process for both internal Inspire CAPAs as well as supplier corrective and preventive action requests (SCARs).

• Lead and coach cross-functional teams to resolve quality issues and navigate the CAPA process.

• Monitor CAPA deliverables, CAPA timelines and trend both CAPAs and SCARs.

• Schedule CAPA team meetings and monthly CAPA management reviews.

• Report on CAPA progress at monthly CAPA meetings as well as Quality management reviews.

• Support all aspects of CAPA activity, including CAPA owner assignment, utilization of root cause tools (i.e., 5 whys, Is/Is Not, Ishikawa, etc.), verification of effectiveness checks and Quality approval for CAPA closure.

• Partner with Inspire product quality and manufacturing teams to support supplier corrective actions.

• Provide audit support for both the CAPA and SCAR processes.

• Partner with Material Quality to develop SCAR timelines and process monitors.

• Support non-conformance (NCR) process and process trending.

• Participate in the development of quality work instruction and procedural updates as assigned.

QUALITY SYSTEM RESPONSIBILITIES

• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.

• Complete training requirements and competency confirmations as required for this position within the required timeline.

• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

QUALIFICATIONS

Educational Requirements:

Required

• Bachelor’s degree in a technical or scientific field.

Preferred

• Bachelor’s degree in an engineering discipline such as electrical, mechanical, materials, manufacturing or biomedical.

• Master’s degree in a technical or scientific field.

Required Experience:

• 2 - 5 years minimum experience in quality or design function in the finished medical device industry

• Demonstrated team leadership skills and ability to prioritize, execute and report on projects

• Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)

• Strong project and time management skills

• Demonstrated creative and effective problem solving and original thinking for compliance solutions

• Ability to work on multiple tasks concurrently with changing priorities

• Proficient with MS Word, Excel and PowerPoint

Preferred Experience:

• Experience with Class III active implantables

• Experience with the corrective action process, supplier corrective action requests, nonconformance resolution, field corrective actions and/or product recalls.

• Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.

• ISO 13485 certified auditor or RAB auditor

• ASQ certifications; CRE, CQM, CQE, CQA etc.

#LI-Onsite

The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.

Salary

$70,000—$90,000 USD

BENEFITS AND OTHER COMPENSATION

Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):

• Multiple health insurance plan options.

• Employer contributions to Health Savings Account.

• Dental, Vision, Life and Disability benefits.

• 401k plan + employer match.

• Identity Protection.

• Flexible time off.

• Tuition Reimbursement.

• Employee Assistance program.

• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com.

Inspire Medical Systems participates in E-Verify.