Quality Assurance Technician IV

Merit Medical Systems, Inc.•South Jordan, UT

46d

About The Position

Performs non-routine quality technical assignments of substantial variety and complexity, under general supervision and guidelines.

Requirements

Education equivalent to a High School Diploma with seven years previous work related experience.
Excellent analytical skills and the ability to solve moderately complex technical problems.
Excellent organizational and interpersonal skills.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
Ability to work well as a team member.

Responsibilities

Generates Engineering Change Notifications (ECNs) to update Quality System documentation such as: procedures, drawings, BOM/routers, workmanship standards, test methods, and/or inspection criteria.
Initiates internal/external nonconformance and responsible for assuring all phases are complete.
Evaluates internal/external nonconforming product in determining appropriate root cause, disposition and corrective action.
Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed to prevent unintended use. May include performing inventory management transactions.
Ensures external NC returns are appropriately handled, decontaminates (as needed) and segregated to expedite investigation.
Evaluates product placed in Quarantine/on hold to assure that it's dispositioned in a timely manner.
Performs dimensional audit/inspections on complex test equipment of various degrees of difficulty to verify product meets specification.
Audits and inspects the production process and product to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations. May include final review and close-out of DHR.
Assists in product and process testing, the collection of data, and generation of reports.
Perform trending analysis and facilitate the identification and correction of failure modes and process/product improvements.
Identifies training needs, develops training plans and performs training of technicians, Quality auditors or Production employees.
Assist Quality Engineering with the identification and control or risks.
Evaluates the manufacturing work environment to ensure it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
Collect and submit information for material characterization testing such as MEM/IR.
Research customer inquiries into Merit's compliance to applicable standards. Generate custom customer responses.
May assist with the supervision of technicians to include assigning work, ensuring proper completion of assignments and processes, and assisting with performance appraisals.
May participate in design and development activities.
Performs other related duties and tasks as required.