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Sr. Quality Engineer

Marion, NC 28752

Posted: 12/05/2023 Employment Type: Contract Job Category: Engineering Job Number: 589815 Is job remote?: No Country: United States

Job Description


SUMMARY:
Provide Quality Engineering support to manufacturing and product development teams for mechanical devices. Implement quality improvement projects and participate in quality activities and support a factory-focus team for a production line. Provide support for released products, evaluate field returns, and support the incoming inspection department and in-process inspections where required. Perform component qualifications and validations to support key development and continuous engineering projects. Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications, and be a factory-focus team member. Perform return product investigations for product complaints. Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines. Perform key deliverables in support of development and continuous engineering R&D projects, which include: mold tool qualifications, component qualifications, design and product risk assessments, shelf life validations, and sterilization validations. Work with manufacturing and R&D engineers to prepare manufacturing work instructions, material specifications, and inspection documentation for new products. Set inspection requirements, set inspection methods and inspection sampling plans. Support quality control inspectors with new product inspections and quality issues that arise during inspections. Support and test component changes to current products. Support internal audits and supplier audits.

Experience/Background:
  • Self-motivated worker Strong communication skills Working knowledge and understanding of mechanical drawings Strong problem solving, technical writing, and statistical analysis skills Preferred experience with supporting a manufacturing product line B.S. degree in Engineering 3-5 years in an engineering role within a Medical Device company, 2 year minimum in Quality Engineering function.
  • Must have working experience of GMP and ISO 13485 requirements.
  • Sitting/standing 8 hours per day.
  • Light lifting may be required on occasion.
  • Ability to work under a microscope
  • Ability to be in a clean room environment with varying humidity levels
  • Ability to travel occasionally.

Target pay: 50-55/hr

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 Marion, NC

Ready to take your career to new heights? Explore job opportunities in the beautiful Marion, North Carolina area! Nestled in the picturesque Blue Ridge Mountains, Marion offers a perfect blend of small-town charm and big-city amenities. With a thriving arts community, including galleries like the McDowell Arts Council Association and the historic Carson House, as well as the captivating State Theatre of Marion, there are endless cultural experiences to enjoy. Indulge in delicious Southern cuisine at local eateries like Bruce's Fabulous Foods, and take advantage of the nearby hiking trails in Pisgah National Forest for the perfect work-life balance. Join us in Marion, where career growth meets tranquility!

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.