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Sr./Lead Quality System Specialist

The Select Group Lexington Contractor
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Sr./Lead Quality System Specialist - LEXINGTON, MA

The Select Group is looking for an experienced Quality System Specialist for one of our clients in Lexington, MA!

QUALITY SYSTEM SPECIALIST REQUIREMENTS

  • Experience dealing with customer complaints (complaint handling)

  • Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807)

  • 3+ years' experience with quality system support activities in an FDA regulated environment

  • Experience with CAPA Management System

QUALITY SYSTEM SPECIALIST DAILY RESPONSIBILITIES

  • This position supports full, ongoing compliance to all applicable FDA medical device regulatory requirements
  • Following MDR procedures and complaint investigation
  • Determine Medical Device Reportability
  • Perform internal audits and external supplier audits
  • Perform corrective and preventative action on non-conforming products

About The Select Group:

We are TSG - a fast-growing technical services firm serving the U.S. and Canada. We open doors to diversified prospective employers who respect and value your ambitions, your pursuit of a meaningful career, and your particular skill-set. We offer interview guidance, an impressive referral program, and partner with you to find work that drives you. Learn more about us in our URL blocked - click to apply or visit us at URL blocked - click to apply Sign up to receive weekly job alerts in your inbox by joining the URL blocked - click to apply

We have the privilege of impacting lives, so let us impact yours.

The Select Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

 

Recommended skills

Corrective And Preventive Action (Capa)
Quality Management Systems
Management Systems
Investigation
Title 21 Of The Code Of Federal Regulations
Medical Device Reporting
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Job ID: TheSelectGroup_48271

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Our story is one of perseverance and willpower. Sheldon Wolitski founded our company in 1999, leading our agency through uphill challenges on the pathway to success.

A native Canadian, Wolitski moved to the US to attend the University of Alabama - Huntsville. After graduating, Wolitski began working with several prestigious staffing companies in Huntsville. Armed with training and experience, Wolitski decided to venture out, and so he began fulfilling his lifelong dream of entrepreneurship.

While the company was flourishing, but still in its infancy, unforeseen tragedy struck America on September 11, 2001. Soon to follow was the dot-com bubble burst in 2001, and a cascading economic downturn.

Wolitski used every tool at his disposal to keep the ship afloat — at one point even maxing out a credit card to pay the bills. Learning from the uncertainty of the situation, he began adjusting his business model to better meet client demands, offering permanent, temporary and contract jobs. That versatility proved invaluable.

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