Merit Medical Systems, Inc.
Quality Assurance Technician IV
Merit Medical Systems, Inc., South Jordan, Utah, United States, 84095
Why Merit?
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 non-routine quality technical assignments of substantial variety and complexity, under general supervision and guidelines.
ESSENTIAL FUNCTIONS PERFORMED
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.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
Lifting – Not to exceed 50 lbs. – local practice may apply.
Writing
Sitting
Standing
Bending
Vision
Color perception
Depth perception
Reading
Field of vision/peripheral
Fine motor skills
Noise
Chemical vapors
Soldering fumes
SUMMARY OF MINIMUM QUALIFICATIONS
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.
COMPETENCIES
NC generation/distribution/closure
ECN generation/review/approval
Computer skills
Problem solving
Training skills
COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.
As an eligible Merit employee, you can expect the following:
Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
Medical/Dental & Other Insurances (eligible the first of month after 30 days)
Low Cost Onsite Medical Clinic
Two (2) Onsite Cafeterias
Employee Garden | Gardening Classes
3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
#J-18808-Ljbffr
WORK SHIFT DAY (United States of America)
SUMMARY OF DUTIES Performs non-routine quality technical assignments of substantial variety and complexity, under general supervision and guidelines.
ESSENTIAL FUNCTIONS PERFORMED
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.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
Lifting – Not to exceed 50 lbs. – local practice may apply.
Writing
Sitting
Standing
Bending
Vision
Color perception
Depth perception
Reading
Field of vision/peripheral
Fine motor skills
Noise
Chemical vapors
Soldering fumes
SUMMARY OF MINIMUM QUALIFICATIONS
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.
COMPETENCIES
NC generation/distribution/closure
ECN generation/review/approval
Computer skills
Problem solving
Training skills
COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.
As an eligible Merit employee, you can expect the following:
Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
Medical/Dental & Other Insurances (eligible the first of month after 30 days)
Low Cost Onsite Medical Clinic
Two (2) Onsite Cafeterias
Employee Garden | Gardening Classes
3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
#J-18808-Ljbffr