Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 4 days agoWe saw it 66 min after it went up

Quality Engineer, CAPA Administrator

Inspire Medical Systems Inc.44 open roles

Pay
$70,000 – $90,000 a year
Where
Minneapolis, MN
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowQuality Engineer, CAPA AdministratorInspire Medical Systems Inc. · Minneapolis, MN

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Inspire Medical Systems Inc.'s own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market. Inspire Medical Systems Inc. postings stay open a median of 6 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 4 days ago

Inspire Medical Systems Inc. median: 6 days open

The posting

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.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Inspire Medical Systems Inc.'s own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Inspire Medical Systems Inc.'s form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Inspire Medical Systems Inc.'s answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.