Quality Assurance Engineer

4 weeks ago

oakland, United States ClinLab Staffing Full time

The Quality Engineer – Post Market will be responsible for managing, improving, and measuring elements of the quality system to remain in alignment with regulatory and business needs. This position ensures that the solid execution of assigned programs remain consistent with the quality policy, manual, and overall company values. The ideal candidate has a solid understanding of engineering, lean, and statistical concepts and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Essential Job Functions:

  • Responsible for receiving, processing, investigating, and trending customer complaints
  • Interact with Engineering, Regulatory, and Clinical functions to ensure complaints are properly assessed
  • Provide oversight and management of the CAPA program
  • Maintain tracking and trending files for assigned QMS elements and generate status reports as needed
  • Identify and lead continuous improvement and lean opportunities for assigned processes including developing and updating related procedures and forms
  • Perform Internal Audits and support External Audits (government agencies, notified body, etc.)
  • Act as back-up for the deviation, nonconformance, and other QMS processes as necessary
  • Assist with various special, ad hoc projects and other duties as assigned

Competencies:

  • Integrity - We act in all ways with respect and transparency, ethically and honestly, with everyone. Our work represents who we are, as we create products we can proudly recommend to our loved ones
  • Creativity - We are passionate trailblazers, relentless in our pursuit of continuous improvement
  • Collaboration - We are only successful together, operating as one diverse and inclusive team with each other and our customers
  • Determination - We are passionate, dedicated, and tenacious about our goals
  • Moved by Urgency - Patients depend on us delivering our products with enthusiasm, efficiency, and diligence. Our obligation and privilege is to drive urgency on patients’ behalf

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand, walk, sit, and file records. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Regular travel between Collagen Matrix sites may be required. Travel for off-site training or supplier audits may be required.

Supervisory Responsibilities:

This position does not manage staff but does oversee associated programs.

Education, Experience and Certification:

  • B.S. in engineering or an alternative Bachelor’s degree program plus 2-5 years of experience in a Quality Engineering role, or an equivalent combination of education and experience.
  • Certification as a quality engineer (CQE) and/or quality auditor (CQA) is preferred
  • Green Belt, Black Belt, or other continuous improvement certification is desirable
  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)
  • Fundamental understanding of QSR/ISO regulations (ISO 13485 and 21 CFR 820)
  • Exceptional problem-solving skills including ability to apply risk analysis (e.g. FMEA), error proofing, process control, and process capability methods to process improvements
  • Ability to listen and clearly communicate verbally, in writing, and in person to people at various levels of the organization
  • Ability to prioritize and multitask in a high energy fast-paced environment
  • Software knowledge including Microsoft Word, Excel, and PowerPoint

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