Quality Engineer, CAPA Administrator

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.
• 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.