Description:

　　Partner with manufacturing team to lead/support quality engineering activities with contract manufacturers (e.g., IQ, OQ and PQ support, non-conformanceresolution, temporary authorities, labeling validations, and deviations, etc.)

　　Manage non-conformance, deviation, and temporary authorization processes for contract manufacturers

　　Manage, lead, and coach cross-functional teams with contract manufacturers to resolve quality issues and navigate the CAPA process.

　　Conduct first article inspections (FAIs) on finished medical products.

　　Provide expertise on finished device specifications as well as generating and approving ECOs.

　　Generate and approve design history file documents, device master record documents and supplier change request records.

　　Lead IP development processes for warehouse inspections of new products and revise existing IPs for contract manufacturers as needed.

　　Lead contract manufacturer (supplier) audits.

　　Support manufacturing risk management activities (i.e., pFMEAs) at suppliers.

　　Lead special projects (e.g., dual sourcing, metrics, etc.) along with supplier product improvement processes at the direction of quality management.

　　Participate in product performance reviews and emerging quality reviews; support any resulting corrective/preventive actions.

　　Support QMS audits with both internal and external auditors.

　　Ability to work efficiently and effectively in both a paper-based and electronic QMS.

　　Recommend process improvements, driving both efficiency and compliance.

　　Skills:

　　Quality engineering, Supplier quality, engineering change orders, change management, Quality assurance, Manufacturing environment, Quality management, Medical device, iso 13485, Capa, gmp, first article inspection, risk management, manufacturing quality, fda compliance, six sigma, supplier quality assurance

　　Top Skills Details:

　　Quality engineering, Supplier quality, engineering change orders, change management

　　Additional Skills & Qualifications:

　　5 years minimum experience in medical device

　　5 years minimum experience in a product, manufacturing quality (process), material or component quality engineering position

　　Knowledge of ISO and FDA Quality System Requirements (e.g., ISO 13485; FDA 21 CFR Part 820)

　　Demonstrated team leadership skills and ability to prioritize, execute and report on projects

　　Experience with engineering tools such as; dFMEA, pFMEA, SPC, etc.

　　Working knowledge of process improvement techniques such as Six Sigma, Lean Sigma, Proof of Station, etc.

　　Strong project and time management skills

　　Demonstrated creative and effective problem solving and original thinking for compliance solutions

　　Ability to work on multiple tasks concurrently with changing priorities

　　Proficient with of MS Word, Excel and PowerPoint

　　Work Environment

　　Business casual attire and very understanding when it comes to a need to work from home from time to time (weather, family, etc.).

　　Business Challenge

　　This position must provide expertise and leadership in the areas of finished medical device manufacturing, product inspection/test, manufacturing process monitoring and control implementation, sterilization, labeling, supplier development, audit and supplier management. This person is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance. This position will work with Development, Operations, Manufacturing, Regulatory and other Quality functional areas to ensure work is completed in accordance with procedures and geographic regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision.

　　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.