Actalent Services is seeking to add a Quality Engineer to support our manufacturing client in Canby, OR. Our client specializes in the manufacturing and production of Medical Device and Scientific Equipment.

　　Duties:

　　-Creation of quality documentation and development of SOPs in support of company’s QMS

　　-Proactive review and improvement of systems and processes

　　-Maintaining accurate quality documentation

　　-Working closely with manufacturing staff to ensure quality protocols are followed and documentation is correctly maintained

　　-Inspection and testing of various parts of manufacturing including products, components, processes, and comparing against predefined standards

　　-Analyzing problems reported and developing improvements to overcome them

　　-Statistical analysis of manufacturing data and creation of reports for other staff members

　　-Continuous improvement in the manufacturing process

　　-Performs supplier quality system audits.

　　-Performs receiving, in process and out of box inspections.

　　-Supports and or leads all areas in

　　a.Risk Analysis

　　i. PFMEA

　　ii. FMEA

　　b. Root cause Investigation

　　c. Corrective action

　　d. Preventive action

　　-Works with cross functional teams for QA/QC improvement.

　　-Performs validation activities for current and new products.

　　-Participates in the Material Review Board (MRB)

　　Additional Skills & Qualifications:

　　-Excellent interpersonal, communication, teamwork and organization skills.

　　-Knowledge of ISO-13485 or ISO-9001 and FDA QSR.

　　-Knowledge of the FDA’s Part 21CFR, Section 820 (Nice to Have)

　　Experience Level:

　　Intermediate Level

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.