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 II
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).
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With increasing levels, the Quality Engineer will be expected to provide increasing leadership and mentoring along with more cross functional interaction both internally and externally.
Duties/Responsibilities
- Participates on teams to ensure robust application of appropriate design and manufacturing controls.
- Supports product development engineers to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
- Advises project teams on compliance related to regulations, procedures, and requirements.
- Collaborates with engineers and leadership to ensure quality and completeness of design history files, risk management, validation, and change orders.
- Manages Non-Conforming Material Reports system and dispositions all non-conforming product.
- Enhances and drives product risk management activities. Ensures identified activities and mitigations are executed.
- Participates in technical discussions and risk-based decision making.
- Develops and executes strategies to close verification and validation gaps in an efficient, technical, and compliant manner.
- Identifies opportunities and recommends improvements to design and development process; drives continuous improvement.
- Reports status updates on assigned responsibilities and goals; escalates issues in a timely manner.
- Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and manufacturing process.
- Bachelor's degree in an engineering or science discipline
- 3-5 years of experience working in quality assurance role in a regulated environment*
- Experience working with implantable devices preferred
- Experience applying quality regulations and standards preferred (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
- Experience with CAPA and failure investigation tools and techniques.
- Practical experience with quality, risk, and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
- Ability to identify problems, review related information, develop and evaluate options, and implement solutions
- Skilled oral and written communicator
- Proven track record of success in teamwork
- Ability to be flexible in a dynamic work environment with shifting priorities.
- Knowledge of ERP Systems (SAP preferred) and intermediate Microsoft Office; intermediate/advanced level Microsoft Excel skills.
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.