We are looking for a Mechanical Inspector (CMM) at our Methuen, MA location! This is a long term opportunity for someone looking to grow in their career.
- 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