We are looking for a Quality Technician in Methuen, MA!
The Quality Technician will be responsible for ensuring compliance in support of the product life cycle as well as supporting the QC function to ensure conformance to specifications using fixed or pre-set measuring instruments. The Quality Tech works cross functionally with Operations and Engineering to continuously improve quality for key system components, assemblies, and products by implementing process controls and implementing effective quality assurance plans.
- Work with engineers and other personnel to evaluate complaints and returned products.
- Participate in continuous improvement projects and corrective and preventive action projects.
- Provide QA support for process development.
- Perform source inspections at Supplier locations.
- Maintain device history records.
- Perform in-process manufacturing record reviews and approvals representing Quality.
- Operate and program coordinate measuring machine (CMM) for incoming materials
- Generate CMM inspection reports
- Maintain calibration/PM files in accordance with standard operating procedures by organizing and documenting maintenance records and equipment calibration history into the electronic database
- Run weekly report for tools coming due for PM and calibration and assist in scheduling calibration as required
- Assist with equipment qualification and process validation (IQ/OQ/PQ)
- Support inspection process development and qualification activities (Test Method Validation).
- Ensure individual performance meets established goals and objectives.
- Establish, follow, and improve company procedures as needed to maintain compliance and meet business goals and objectives.
- Provide written and oral reports to supervisor or other management personnel to keep them informed of activities and results.
- Maintain a cooperative and motivational attitude with co-workers.
- Perform other tasks as requested by supervisor to meet business goals and objectives.
- Adhere to all Company policies, rules, procedures and housekeeping standards.
Education and experience
Requires a high school diploma, or equivalent, and a minimum of 3 years of progressive experience in a technical quality support role or similar experience. Preferred candidate will have an associate’s degree or higher with at least 3 years of relevant experience. Experience working in an FDA regulated medical device environment is preferred.
Other Knowledge, Skills, Abilities or Certifications
- Excellent oral and written communication skills.
- Certification in IPC-A-610/620
- Familiarity with GMP environment; reading & checking Bills of Materials, schematics, and machine/assembly drawings.
- Ability to use basic inspection test equipment such as: multi-meters, calipers, CMM, bore & ID gages, depth and height gages, etc.
- Working knowledge of Windows and Microsoft Office
- Proficient in the programming and operation of CMM machinery for QC inspection of various components.
- Strong mechanical aptitude.
- Experience working with calibration software such as ProCal is a plus
- Keep all inspection files up-to-date and accurately processed in a timely manner
- Demonstrated knowledge of Excel, Word, and PowerPoint
- Ability to work under minimum supervision with a high degree of organizational and technical competence
- Ability to function well under pressure and expend effort to meet schedules and deadlines