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QA Specialist

Mansfield, MA 02048

Posted: 03/01/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 544381-1 Is job remote?: No Country: United States

Job Description


This position is self-directed and is responsible for performing quality assurance tasks and activities with minimal guidance and supervision, detail oriented and strong computer skills to support the function of Remediation of Design History Files (DHF), Clinical Evidence Reports (CER) and Technical Files (EU-MDD/MDR Focused). Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Demonstrates an understanding of the relevant regulations, standards and operating procedures. Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. This role is an Independent Contributor, and interaction is potentially with all levels of the organization. This position reports to R&D Manager. Receives general guidance may receive more detailed instruction on new projects.

Responsibilities for Quality Specialist:
  • Lead document control functions, assuring revision control, reviews, updates and data integrity of all documents managed in the Oracle Agile PLM System.
  • Converting and routing of documents in the Oracle Agile System.
  • Works with global team members for approvals and product structures.
  • Demonstrates knowledge of quality systems.
  • Works well cross-functionally and has the ability to interpret standard operating procedures and regulatory requirements as well as educate others on those requirements.
  • Works on projects of limited scope and complexity.
  • Prepare and file all Device History Records and other documents, maintaining organization and retrievability.
  • Perform, document, and review incoming and final inspections as required.
  • Follows established procedures to resolve readily identifiable technical problems.
  • Supports multiple aspects of compliance for the Quality System as needed.
  • 2 years of experience

Required/Preferable Knowledge, Skills and Abilities for Quality Specialist:
  • Use of Oracle Agile Software
  • Demonstrates knowledge of quality systems
  • Proficiency in Microsoft Office Software (Microsoft Word, Excel, et. al.)
  • Excellent organizational skills
  • Ability to assertively interact and communicate with people at all levels of the organization
  • Good technical writing skills, grammar
  • Ability to manage time and prioritize, as well as multi-task
  • Ability to handle highly confidential business information
  • Strong attention to detail
  • Ability to think proactively
Education:
  • Equivalent work experience, preferred experience in related field, preferred strong Microsoft Office Products usage

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Mansfield, MA

Ready to embark on your next career adventure in Mansfield, Massachusetts? Explore our job opportunities in this vibrant town filled with charm and growth potential. Nestled between Providence, Rhode Island, and Boston, Massachusetts, Mansfield offers a perfect balance of small-town charm and big-city opportunities. Enjoy live music at the Xfinity Center, catch a game at Gillette Stadium, or hike the trails at the nearby Borderland State Park. With a rich history, delicious seafood cuisine, and a thriving arts scene including the Mansfield Music and Arts Society, this area provides an enchanting backdrop for your career journey. Discover the perfect job match in Mansfield today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.