Quality Engineering Supervisor, NPI

About Us:

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.

Quality Engineering Supervisor, NPI:

Provide leadership and direction in Design Assurance policies and procedures, as well as New Product Introduction (NPI) quality improvement programs. The Quality Engineering Supervisor, NPI ensures that policies and procedures of the organization comply with all applicable laws and regulations. Enhance customer satisfaction through the delivery of high-quality medical devices and ensure compliance with applicable regulations.

Duties/Responsibilities:

  • Build successful teams, develop and lead people to achieve continuous design assurance improvement and drive change.
  • Develop and implement New Product Introduction quality system management in alignment with the Company's long term strategy.
  • Educate non-experts, internally and externally, on complex design assurance topics.
  • Plan and manage New Product Introduction resourcing and activities in accordance with annual operating budget.
  • Ensure Acumed's products are of the highest quality, lowest risk and greatest benefit to the customer.
  • Ensure all product designs are developed in compliance with the regulations of the markets in which we sell product.
  • Maintain quality policies and ensure efficient use of New Product Introduction Quality Engineering.
  • Assure engineering design processes and manufacturing processes are conducted in compliance with Acumed policies and procedures.
  • Ensures Design Assurance is compliant with all applicable regulations including those issued by FDA, SFDA, JPAL, etc.
  • Champion the quality system management strategy within the organization to gain compliance and commitment at all levels from the executive team to the shop floor.

Qualifications:
  • Bachelor's degree in an engineering or science discipline; advanced degree preferred.
  • Four or more years of experience in medical device manufacturing or applicable experience.
  • Prior experience in quality supervisory role preferred.
  • Proven problem-solving skills and the ability to train teams to resolve various issues using available tools.
  • Familiarity with Lean Manufacturing concepts.
  • Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook).
  • Self-motivated, able to work with little supervision.
  • Strong verbal and written communication skills.
  • Ability to read and speak English sufficiently to understand and complete all necessary documentation.


Acumed and ACUTE are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net .


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