Senior Quality Inspector

Position Summary

The Senior Quality Inspector is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Senior Quality Inspector supports manufacturing and servicing operations by performing incoming component and in-process product inspections which are more complex requiring the use of sophisticated measurement systems and instrumentation. Senior Quality Inspectors identify and document component, process and product non-conformances and lead investigation/root-cause countermeasure activities. They work with operations team members to perform and document problem-solving investigations. In addition, Senior Quality Inspectors may oversee device history record reviews and manage calibration and environmental monitoring processes.

Duties

• Conducts complex incoming component and in-process product inspections.
• Initiate and supports quality investigations and associated problem-solving / root-cause activities.
• Generates incoming inspection plans.
• Identifies and documents product and process non-conformances.
• Identifies opportunities for process continuous improvement.
• Participates on a Material Review Board to review and process non conformance reports.
• Supports supplier quality improvements through SCAR’s and other site actions.
• Oversees DHR reviews and batch record release.
• Tracks, trends and reports quality data for assigned areas.
• Performs site calibration activities and recordkeeping for inspection equipment.
• Executes environmental monitoring processes and recordkeeping.
• Complete other duties as assigned.

Education Degree

Required Experience e Competencies

• 1-3 year experience required in a quality/manufacturing environment or other technical production tasks.

• Ability to work in a fast-paced environment with strict deadlines

• Ability to generate detailed, high quality documentation

• Ability to work with others in analysing and solving technical problems

• Teamwork: Collaborates with others. Works in a professional manner to support team actions. 

• Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.

•  PC experience and working familiarity of common desktop applications including Excel and Word

Additional Information

We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status,  sex, sexual orientation, gender identity, genetic information, and any other category protected by state or local law.