Exercise initiative and ingenuity to deal with varying circumstances, changing conditions and proceed when general instructions and established methods indicate action to be taken, referring unusual problems to supervisor performing activities.
Assures optimum control of quality so that raw material and/or finished products conform to existing requirements, thus assuring process performance and compliance against Ethicon's Quality Systems Regulation (QSR), Good Manufacturing Practice (GMP), and ISO requirements for the manufacturing process.
Performs raw material, tooling, and/or in-process tests and reviews.
Management of product (raw material and finished good product) placed in quarantine cages.
Reads and interprets results, and performs trend analysis as required.
Recommends, amends and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.
Utilize document change control system to own periodic review and Standard Operating Procedure (SOP) creations as well as revisions.
Performs non-conformance investigations including documentation within the non-conformance, CAPA and internal audit systems.
Lead Kaizen's with cross-functional teams to ensure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
Provide training and education to peers and support groups as needed.
Provide leadership to other technicians and wage associates.
Assist Quality Engineer on day-to-day activities.
Support internal and external audits and inspections.
Accept or initiate special projects.
Plan and organize assignments to ensure completion of projects in a timely fashion after receiving minimal instructions as to content and objective.
Meets functional area goals and yearly strategic imperative project timelines.
Comply with all applicable quality management systems, environmental, safety, and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
EDUCATION and/or EXPERIENCE:
A minimum of a High School diploma, G.E.D. or equivalent required.
Associate's degree in Engineering or a related technical discipline is preferred.
A minimum of 5 years of related quality assurance experience (Manufacturing, Production, Engineering, Quality) experience in a regulated environment is preferred.
Experience in the QSR/ISO regulated Medical Device industry is preferred.