Quality Assurance Specialist

Job Description

Job Description

Annual Salary Range : $68,000-$82,000

Join Biocoat , a global leader in developing, manufacturing, and applying hydrophilic coatings on medical devices. Our Quality team is looking for a full-time  Quality Assurance Specialist !

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Review, approve, and document batch records and release of product
• Administration and of all QMS documentation
• Document Control and Training SME and electronic QMS (e.g., Grand Avenue) administrator
• Implement, review, and facilitate investigations including Corrective and Preventive Actions (CAPA)
• Assist with and / or lead investigation and resolution of customer complaints
• Assist in and / or lead the management of change controls / ECOs and associated activities
• Lead Material Review Board meetings and facilitate material and documentation dispositions as needed
• Communicate deficiencies and / or compliance issues to QA / RA management
• Responsible for driving goals and initiatives for continuous improvement of procedures, processes, and systems
• Compile data and report QMS metrics as required
• Administer and deliver Quality Assurance training
• Coordinate and perform audits (internal, process) as required
• Support and organize audit preparation and performance activities
• Support testing and release activities for Quality Control (QC)

QUALIFICATIONS & REQUIREMENTS :

Physical Requirements

Physical Demands : Stooping, turning, bending, squatting, kneeling and the ability to lift to thirty pounds, ability to reach to seven feet unassisted; constant / repetitive standing; requires normal, correctable vision and hearing, and the ability to accurately discern color as necessary to perform job functions.

This position may require regular and sustained laboratory time around chemicals which may be hazardous and may work within a Class 7 cleanroom for periods of time.

What Biocoat Offers :

Biocoat is an is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as a qualified individual with disability, or any other protected characteristic under law.

Biocoat Human Resources leads recruitment and employment for Biocoat. Unsolicited resumes sent to Biocoat from recruiters do not constitute any type of relationship between the recruiter and Biocoat and do not obligate Biocoat to pay fees should we hire from those resumes. We ask those external recruiters and / or agencies not contact or present candidates directly to our hiring managers or employees.

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