Industry leading medical device manufacturer is seeking a Quality Engineer to support the product release process for new projects for Finished Goods.

　　Description:

　　You will be the primary contact between Quality Assurance and Operations for Finished Goods. This person will provide expert QA and scientific support to Operations, in ensuring goals and objectives are achieved for this operation.

　　Complete Lot Review and Release for Finished Goods.

　　Complete Sterile load reviews

　　Continuous improvement and development of acceptance and inspection activities for Finished Goods.

　　Introduction of best practices in acceptance and inspection activities.

　　Co-ordinate with business units to ensure that acceptance and inspection activities are appropriately carried out.

　　Ensure that a consistent approach to acceptance and inspection activities is developed and maintained.

　　Co-ordinate with the business units in relation to non-conformance activities and root cause analysis associated with acceptance and inspection activities, to ensure a consistent approach.

　　Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.

　　Ensure regulatory compliance in area of responsibility to GMP of all medical device’s regulatory agencies (i.e. FDA, IMB and BSI).

　　Provide functional expertise to other support function on quality related issues.

　　Own and drive NC/CAPA’s related to process.

　　Interface with Suppliers for quality Issues.

　　Work cross functionally with such groups as Regulatory, Design Division and Operations to ensure all issues are successfully resolved.

　　Support The Finished Goods Operations in addressing quality metrics, e.g. NC, CAPA, , , Process Changes, , Quality Alert, Product Holds and Recalls.

　　Support site during External Audits. (i.e. FDA, IMB and BSI). Support / act as local subject expert for review, creation and training of divisional/corporate procedures.

　　Responsible for input to Quality Metrics.

　　Ensure system transactions

　　Qualifications:

　　Bachelor of Science

　　3+ years of experience in engineering

　　Knowledge of medical device standards, (FDA, ISO, EUMDR)

　　Experience with lot review and lot release preferred

　　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.