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JOB OBJECTIVE: Perform Quality inspection and analysis activities including:
1. Receiving inspection of purchased components and materials in accordance with written procedures, statistical sampling plans, inspection standards and engineering drawings and specifications, using measuring equipment.
2. In-process and finished device inspection and release activities in accordance with the Device Master Record.
1. Perform first article inspection as well as ongoing receipt inspection of purchased components and materials in accordance with inspection standards and engineering drawings.
2. Perform release activities for final product and subassemblies according to procedures.
3. Provide input to Quality and Engineering departments regarding inspection methods, quality
procedures, and sampling plans.
4. Maintain accurate and timely documentation of receiving, in-process, and final product quality inspections following good documentation practices.
5. Use an ERP system to document status of inspections as well as maintain inspection records.
6. Initiate nonconformance reports according to procedures.
7. Keep records filed in an accurate and timely manner.
8. Perform visual inspection for quality workmanship in accordance with industry standards.
9. Read and interpret engineering drawing and specifications.
10. Apply a variety of sampling plans using random sampling techniques.
11. Maintain and operate measuring tools and equipment in a ready state, including arranging for repairs and calibrations as appropriate.
12. Understand and comply with ethical, legal, quality and regulatory requirements applicable to our business and the products (for example, ISO9001, ISO13485, FDA QSR, Safety, etc).
1. Write and submit process changes for review and approval.
2. Write programs for coordinate measuring machines (e.g. Micro-Vu or Keyence inspection instruments).
3. Complete other tasks, as assigned.
1. High school diploma or GED.
2. 1-3 years of QA inspection, technician or equivalent experience, including mechanical inspection experience, working with calibrated equipment.
3. 1-3 years experience using measuring tools including calipers, micrometers, pin gauges, surface plate, tensile testers, coordinate measuring machines (e.g. Micro-Vu or Keyence inspection instruments).
4. Profient skills and abilities using Microsoft Office especially Word and Excel.
5. Excellent attention to detail.
6. Strong written and verbal communication skills.
7. Experience working independently and in a team environment.
1. Knowledge of Quality System Regulations, ISO13485 Requirements and ASQ/ ANSI Z 1.4 attribute sampling plans, including switching rules.
2. ASQ Quality Technician certification or equivalent.
3. Knowledge of SAP for release documentation.
4. Associates degree or college course work in Engineering or Bioscience disciplines.
5. Prior experience generating metrics associated with inspection activities.
6. Prior experience programming coordinate measuring machines (e.g. Micro-Vu or Keyence inspection instruments).
1. Ability to stand for extended periods of time.
2. Ability to work in a static-free environment.
3. Ability to move objects weighing up to 50 lbs.
4. Ability to use computer and telephone equipment.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.