• 01-Aug-2018 to 31-Oct-2018 (PST)
  • Quality
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Parental Leave, Tuition Reimbursement Program, Tri-Met Pass, Costco Membership Sponsorship, Summer Hours and more!

The Quality Engineer II serves as a resource to product development and manufacturing to improve product quality, reliability, and process capability and participate on teams in identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools. Under general supervision, responsible for quality planning & overall quality of new products being released to the market through participation in product development to ensure product and process conformance to global standards (including FDA and ISO 13485).

• Provide 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.
• Participate on teams to ensure robust application of appropriate design and manufacturing controls. .
• Under supervision, advise project teams on compliance related to regulations, procedures, and requirements. Provide training, guidance and interpretation.
• Work with senior engineers and leadership to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders
• Provide ongoing quality engineering support throughout the product life cycle, including risk management, design and manufacturing changes, and CAPA investigations.
• Under close supervision, enhance and drive product risk management activities. Ensure identified activities and mitigations are executed as agreed.
• Participate in technical discussions and risk-based decision making.
• Under supervision, review verification and validation reports and identify gaps for compliance with Acumed policies and global regulations. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Identify opportunities and recommend improvements to design and development process; continuous improvement.
• Report status updates on assigned responsibilities and goals; timely escalation of issues

• 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 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.

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