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 2 QE2 is responsible for improving product quality, reliability, and process capability during product development and manufacturing. The QE2 is represents Quality on teams responsible for identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools. The QE2 is also responsible for quality planning, including creating inspection plans, and overall quality of new products released to the market through participation in product development to ensure product and process conformance to global standards including FDA and ISO 13485.
Provides quality representation to design control, design verification and validation, design transfer, process validation, risk management, and specification development on assigned product development teams to assure compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485.
Participates on teams to ensure robust application of appropriate design and manufacturing controls.
Advises project teams on compliance related to regulations, procedures, and requirements. Provides training, guidance, and interpretation.
Collaborates with engineers and leadership to ensure quality and completeness of design history files, risk management, validation, and change orders.
Provides ongoing quality engineering support throughout the product life cycle, including risk management, design and manufacturing changes, and CAPA investigations.
Manages Quality Notifications Non-Conforming Material Request system and dispositions all non-conforming product.
Creates and maintains final inspection plans.
Enhances and drives product risk management activities. Ensures identified activities and mitigations are executed.
Participates in technical discussions and risk-based decision making.
Reviews verification and validation reports and identifies gaps for compliance with Acumed policies and global regulations. Develops and executes strategies to close 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.
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.
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 firstname.lastname@example.org.