Acumed
  • 05-Jun-2020 to Until Filled (PST)
  • Quality
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Parental Leave, Paid Time Off, Floating Holidays, Tuition Reimbursement Program, TriMet Pass, Costco Membership, Summer Hours and more!


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 Engineer I

The Quality Engineer is responsible for providing Quality Assurance support to product development and manufacturing to increase product quality, reliability, and process capability. Responsible for identifying, documenting, assessing, correcting and presenting quality issues using risk and root cause analysis tools. Supports quality of new products being released to the market through participation in the product development process to ensure product and process conformance to global standards (including FDA and ISO 13485).

Duties/Responsibilities

  1. Serves as a quality representative to design control, verification and validation, design transfer, and risk management on assigned product development teams ensuring compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485.
  2. Supports projects teams on compliance to the quality standard including regulations, procedures, and requirements.
  3. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
  4. Processes Non-Conforming Material Reports.
  5. Creates and maintains final inspection plans.
  6. Drives product risk management activities for assigned projects by using established processes to identify risk factors for use in decision making. Drives identified risk mitigation activities and mitigation efforts to execution as agreed. Participates in technical discussions and risk-based decision making.
  7. Reviews verification and validation reports and identifies gaps for compliance with Acumed polices and global regulations. Recommends strategies to close gaps in an efficient, technical, and compliant method.
  8. Applies basic theory and technical principles to address moderately complex problems.
  9. Regularly reports status updates on assigned responsibilities and progress to assigned goals.

Qualifications

  1. Bachelor's degree in an engineering or science discipline.
  2. 1-3 years of experience working in quality assurance role, preferably in a regulated environment.*
  3. Experience applying quality regulations and standards preferred (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.).
  4. Knowledge of CAPA and failure investigation tools and techniques required, practical experience preferred.
  5. Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DEO, trend analysis, etc.)
  6. Ability to identify problems, review related information, develop and evaluate options, and implement solutions.
  7. Skilled oral and written communicator.
  8. Ability to work well in teams.Ability to be flexible in a dynamic work environment with shifting priorities.
  9. Intermediate level knowledge of Microsoft Office Suite of programs; advanced level Microsoft Excel skills preferred.

Acumed is an 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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