Acumed
  • 07-Jun-2019 (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 Systems Specialist

The Quality Systems Specialist (QSS) uses independent judgment to design, implement, and manage the Corrective and Preventive Action Program (CAPA), the Internal Quality Audit System, and Field Actions Program related to implicated product.  The QSS implements and maintains the Acumed quality system in compliance with applicable regulations.  Research and implement current regulations to ensure multiple interdependent systems (CAPA, Quality Audit, and Field Actions Program) are updated and compliant with current requirements.  The QSS drives integration of various quality systems to ensure continuous compliance with global quality system requirements and ensures the processes supporting the quality system are robust and support the evolving requirements of Acumed's product line.

Duties/Responsibilities

  • Own and execute all aspects of CAPA program administration ensuring compliance with the quality standard. CAPA program administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms.   
  • Respond to CAPA requests and open new CAPAs when appropriate.
  • Verify CAPAs are thoroughly investigated and accurately documented in the system.
  • Review all CAPAs prior to closure to assure all required actions were completed; perform effectiveness checks at established intervals in a timely manner.
  • Partner with senior leadership to ensure CAPAs are appropriately resourced for closure within a reasonable timeframe.
  • Own and execute all aspects of Acumed's Internal Quality Audit system administration ensuring compliance with the quality standard. Internal Audit system administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms.  
  • In collaboration with the Quality Manager, create, distribute, and maintain the annual internal audit schedule.
  • Coordinate with leaders in other departments to ensure sufficient auditing resources are available to support the audit schedule.
  • Mentor and develop Acumed employees in other departments as internal auditors; coordinate required external certification to qualify internal auditors.
  • Ensure audits are completed on schedule, results are communicated to the appropriate people, and the internal audit findings are promptly closed by collaboration with responsible department leaders.
  • Support the Quality Manager during third party (i.e. Notified Body, FDA, Health Canada, ANVISA) assessments of Acumed's quality system.
  • Assess, report, and implement new and changing regulations or the addition of new markets to the quality system.
  • Execute Field Action activities by coordinating and facilitating the removal of implicated product from the field.
  • Manage the creation and approval of Health Hazard Evaluations (HHEs) ensuring input and agreement from stakeholders
  • Analyze HHEs in preparation for management review.
  • Create, maintain, and disseminate reports and metrics on CAPA system activities, Internal Quality Audit system, and Field Actions for management.

Qualifications

  • Bachelor's degree in an engineering or science discipline required; advanced degree preferred
  • 5-10 years of experience in a quality role in medical device manufacturing.
  • Working knowledge of applicable Code of Federal Regulations and ISO 13485.
  • Extensive knowledge of Quality System Regulation, US FDA, and ISO 13485. Experience with international quality system regulations preferred. 
  • Effective at solving problems and able to train others to resolve issues using available tools.
  • Knowledge and experience with ERP systems, preferably SAP, and its application in a quality-system environment.
  • Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)
  • Self-motivated, able to work with little supervision.
  • Effective at influencing, persuading, and motivating others to change their perspective.
  • Ability to bring people together to negotiate and reconcile differences.
  • Ability to lead and motivate others to work as a team towards a common goal, and a strong balance of strategic and tactical approaches.
  • Proven success in executing improvement plans and activities that achieve expected results.
  • Strong verbal and written communication skills.
  • Ability to communicate at all levels of the organization in order to influence change and drive system improvements.
  • Excellent presentation skills.
  • Ability to communicate complex and technical information so it is easily understood.

 

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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