SUMMARY OF DUTIES
Performs non-routine quality technical assignments of substantial variety and complexity, under general supervision and guidelines.
ESSENTIAL FUNCTIONS PERFORMED
1. Generates Engineering Change Notifications (ECNs) to update Quality System documentation such as: procedures, drawings, BOM/routers, workmanship standards, test methods, and/or inspection criteria.
2. Initiates internal/external nonconformances and responsible for assuring all phases are complete.
3. Evaluates internal/external nonconforming product in determining appropriate root cause, disposition and corrective action.
4. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed to prevent unintended use. May include performing inventory management transactions.
5. Ensures external NC returns are appropriately handled, decontaminates (as needed) and segregated to expedite investigation.
6. Evaluates product placed in Quarantine/on hold to assure that it's dispositioned in a timely manner.
7. Performs dimensional audit/inspections on complex test equipment of various degrees of difficulty to verify product meets specification.
8. 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.
9. Assists in product and process testing, the collection of data, and generation of reports.
10. Perform trending analysis and facilitate the identification and correction of failure modes and process/product improvements.
11. Identifies training needs, develops training plans and performs training of technicians, Quality auditors or Production employees.
12. Assist Quality Engineering with the identification and control or risks.
13. Evaluates the manufacturing work environment to ensure it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
14. Collect and submit information for material characterization testing such as MEM/IR.
15. Research customer inquiries into Merit's compliance to applicable standards. Generate custom customer responses.
16. May assist with the supervision of technicians to include assigning work, ensuring proper completion of assignments and processes, and assisting with performance appraisals.
17. May participate in design and development activities.
18. Performs other related duties and tasks as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting -- Not to exceed 50 lbs. -- local practice may apply.
- Color perception
- Depth perception
- Field of vision/peripheral
- Fine motor skills
- Chemical vapors
- Soldering fumes
- 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.
- NC generation/distribution/closure
- ECN generation/review/approval
- Computer skills
- Problem solving
- Training skills
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.
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.
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)
- No Cost Onsite Dental Clinic | 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
Day in the Life:
Merit Medical Systems