Quality Assurance Technician IV

Merit Medical Systems•South Jordan, UT

10d•Onsite

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. WORK SHIFT DAY (United States of America) SUMMARY OF DUTIES Performs global complaint handling assignments of substantial variety and complexity, under general supervision and guidelines. ESSENTIAL FUNCTIONS PERFORMED Generates and processes complaint records Initiates internal/external nonconformances 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. 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. 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. 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.

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 and processes complaint records
Initiates internal/external nonconformances 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.
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.
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.
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.