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QA/RA Manager – Medical Device startup, CQE, CQA, FDA, ISO 13485


This is a Contract position in Dallas, TX posted August 16, 2021.

If you are a QA/RA Manager for medical device with experience, please read on Based in Irvine, CA, we are an exciting new startup in the respiratory illness medical device space.

We have a team of industry leaders and SME’s on our board and it is time to build out QA and RA.

We are looking for mid-level managers with medical device startup experience ready to hit the ground running.

This is a very exciting time for us and we look forward to meeting you.

Top Reasons to Work with Us This is a startup organization with a possible lower base salary and higher equity/stock options and bonus plan.

Looking for candidates based in Southern California.

What You Will Be Doing Lead the improvement of the Company’s quality system, and work in conjunction with the company employees to ensure ISO 13485, MDSAP, and FDA QSR compliance for devices, including combinations products, as applicable.

Lead implementation and maintenance of Quality Management Systems (QMS), strategy, framework, methodology, infrastructure, and activities to ensure compliance with regulations, including post marketing activities such as complaints, Recalls, NCRs, CAPAs, etc.

Provide oversight, plan and conduct internal and supplier audits as well as vendor qualification.

Collaborate with internal and external partners (e.g.

laboratories, test agencies, manufacturers, packagers) to provide products that meet quality requirements for new and existing products.

Lead Design Controls, Risk Management, Design Verification and Validation activities for new products and product modifications.

Provide statistical technique and sample size guidance.

Lead regulatory applications.

Obtain and maintain the latest regulatory guidance, standards, and requirements.

Prepare and lead regulatory audits.

What You Need for this Position 3-5 Years Of Experience In The Following Medical Device startup Regulatory Affairs Compliance experience in quality assurance Combination product and biotechnology field FDA Quality System Regulatory ISO 13485 MDSAP requirements CE Mark certification / FDA EUA / FDA 510(k) CQE / CQA certifications BS or MS degree in biomedical engineering What’s In It for You Competitive base salary equity/stock options bonus Medical/ dental/vision insurance Flexible Time Off 401k plan and more perks So, if you are a QA/RA Manager for medical device with experience, please apply today Email Your Resume In Word To Looking forward to receiving your resume through our website and going over the position with you.

Clicking apply is the best way to apply, but you may also: Please do NOT change the email subject line in any way.

You must keep the JobID: linkedin : KB2-1644609 in the email subject line for your application to be considered.

Katy Bruce
– Sr.

Executive Recruiter
– CyberCoders Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work
– 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 eligibility verification document form upon hire.

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