Encore Medical - Austin, TX

posted 2 months ago

Full-time - Mid Level
Austin, TX
Miscellaneous Manufacturing

About the position

At Enovis™, we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. In the role of Quality Assurance Engineer - Inspection Focus, you will utilize your comprehensive knowledge of engineering and problem-solving principles to manage a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions. Your work will ensure external safety, quality, and compliance with complex company standards and government regulations. This position provides quality support to the Enovis instrument re-sourcing initiative, which focuses on increasing offshore supplier contributions to our instrument needs. Additionally, you will support the incoming inspection department by collaborating closely with Enovis' instrument suppliers and internal teams to reduce inspection burdens while ensuring high product quality. Your responsibilities will include reviewing inspection strategies and techniques used by Enovis on implant and instrument products, assessing CMM programs for suitability, and partnering with suppliers to develop their inspection capabilities to the extent that they can perform final inspections in lieu of Enovis. You will also author and execute supplier inspection certifications and validations, conduct process capability PQs to reduce inspection, and analyze protocols and reports to ensure quality system requirements are met. Furthermore, you will support Manufacturing and Operations to remedy adverse quality or compliance situations and work on complex special projects as assigned.

Responsibilities

  • Review inspection strategies and inspection techniques used by Enovis on implant and instrument product
  • Review CMM programs for suitability
  • Partner with suppliers to develop their inspection to an extent that they are certified to perform the final inspection in lieu of Enovis
  • Author and execute supplier inspection certifications and validations
  • Conduct process capability PQs to reduce inspection
  • Analyze protocols and reports to ensure quality system requirements are met
  • Support Manufacturing and Operations to remedy adverse quality or compliance situations
  • Work on complex special projects as assigned

Requirements

  • Bachelor's in Science or Engineering and 3+ years of experience
  • Prior background in Medical Device, Aeronautics, Automotive or other highly regulated industry required
  • Must hold a valid passport and be able to travel internationally without restrictions

Nice-to-haves

  • Preferred knowledge of ISO 13485 quality standards
  • Knowledge of technical writing quality and best practices
  • Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization
  • Knowledge of Microsoft Office Suite of software or equivalent
  • Knowledge of CMM programming
  • Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM, and PC-DMIS
  • Prefer CQE, Lean, or 6 Sigma Certification
  • Advanced knowledge of mechanical inspection and the associated inspection equipment
  • Detail oriented and analytical

Benefits

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Spending and Savings Accounts
  • 401(k) Plan
  • Vacation, Sick Leave, and Holidays
  • Income Protection Plans
  • Discounted Insurance Rates
  • Legal Services
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