Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Responsible for insuring compliance with the Quality System Regulation regarding quality and manufacturing processes and methods
• Revise and approve all documentation related to the areas of responsibilities such as: In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records related and others.
• Responsible for routine manufacturing audits of machine parameter and/or set-ups for compliance as well as the product manufactured.
• Perform routine audits of sampling techniques testing.
• Responsible for an immediate notification and awareness to Quality Management of potential Quality situations.
• Provide support regarding mold approval and mold start up evaluations (if applied).
• Gather, analyze, audit and interpret data using SPC methods so as to be able to predict trends and recommend process improvements that would impact favorably on product quality, scrap reduction, DPM reduction, Complaints reduction, price of non-conformance reduction and others.
• Ensure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements.
• Maintains, revise and audits control chart and compute control chart limits as required.

Qualifications:

• Associate degree in science
• Two (2) years of experience in Medical Device Industry
• Experience in measurements instrumentation
• Experience with manufacturing process
• Molding experience
• Experience with Quality System Regulation
• 3rd shift or a weekend (12 hr ) shift (am/pm) Availability.

Job Types: Full-time, Temporary

Experience level:

• 2 years

Schedule:

• 12 hour shift
• 8 hour shift
• Day shift
• Monday to Friday
• Night shift
• Weekend availability

Work setting:

• In-person

Ability to commute/relocate:

• Aibonito, PR: Reliably commute or planning to relocate before starting work (Required)

Experience:

• measuring instruments: 2 years (Required)

Shift availability:

• Day Shift (Preferred)
• Night Shift (Preferred)
• Overnight Shift (Preferred)

Work Location: In person

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