Quality Assurance Manager

Annual Compensation Range: $100,000-$125,000

Biocoat is committed to providing the best in developing, manufacturing, and applying coatings on medical devices. We are a positive and collaborative team with a passion to helpimprove patient care by producing a safe and efficient product.

We have an opportunity for a Quality Assurance Manager who would lead the QA divisions of the QA/RA department. The QA Manager would have oversight of all quality systems to maximize product quality per ISO 13485 guidelines. This position is critical in ensuring products and processes meet defined internal, customer and regulatory specifications and standards.

Responsibilities:

• Management and oversight of the QA divisions of the QA/RA department; Assistance in oversight of the Quality Control (QC) and Quality Engineering (QE) divisions as needed
• Review and approve batch records and supporting documents for production activities and release of product, ensuring all associated discrepancies and deviations are documented and closed appropriately
• Administration of QMS documentation including authoring, formatting, and reviewing quality procedures, templates, forms, and reports, and developing/revising/implementing additional procedural and work instructions as necessary
• Subject Matter Expert (SME) for the Quality Management System (QMS) and Deputy Management Representative; Serves as back-up for the Sr. Director/Director, QA/RA
• Electronic QMS (e.g., Grand Avenue) administrator
• Implement, review, and facilitate investigations: perform and lead root cause analysis groups, risk analysis, and effectiveness monitoring and close Corrective and Preventive Actions (CAPA)
• Assist with and/or lead investigation and resolution of customer complaints, including direct customer communication
• Assist in and/or lead the management of change controls/ECOs and associated activities
• Communicate deficiencies, compliance issues, and/or negative trends to the Sr. Director/Director, QA/RA
• Responsible for driving individual and department goals and initiatives for continuous improvement of procedures, processes, and systems
• Project lead for critical organization projects and key initiatives, often cross-departmental
• Management Review and Quality Review leader
• Create and deliver training materials for quality-related functions and topics for the organization as needed including onboarding of new employees
• Coordinate and perform audits (customer, regulatory, supplier, internal, process) as required
• Support and ensure completion of all audit preparation and resolution activities
• Support testing and release activities for Quality Control (QC) as needed and appropriate
• Teach and mentor staff to drive and enforce quality culture within the organization
  
  

Skills & Requirements:

• Bachelor’s degree in a Scientific or Life Science field or equivalent work experience
• 8-10 years of experience in a Quality function under ISO 13485 (3 years in a management position with direct reports); Customer interaction experience required
• External certification, (CQA, CQE, RAC, etc.) is highly desirable, or at a minimum, a clear path to achievement through advanced degrees or training
• Excellent technical writing skills with great proficiency in spelling, grammar, formatting, and completeness of documentation
• Analytical approach to problem solving; critical thinker; uses data to substantiate decision making
• Prior experience with eQMS systems highly desired
• Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint
• Ability to work proficiently and independently in a regulated manufacturing setting
• Independent, self-starter; able to complete assigned tasks in a timely manner with minimal day-to-day direction; keen attention to detail and ability to follow directions
• Represent the company in a positive and professional manner internally and during supplier, customer, and regulatory visits
• Ensures all interactions are consistent with company values and others are treated with dignity and respect
• Ability to effectively present and lead in formal (incl. customer), one-on-one, and group situations
• Strong interpersonal skills and ability to work with others in a positive and collaborative manner
• Organized with ability to identify and manage priorities
• Ability to follow and adhere to all Safety guidelines and processes including wearing appropriate lab gowning and other PPE as required
  
  

What Biocoat Offers:

• Competitive salary, eligible for a discretionary bonus
• Benefits (medical, dental, vision, critical illness, hospital indemnity, and accident insurance)
• Life insurance, short- and long-term disability paid by the company
• 401(k) plan with an immediate company match
• Paid time off
• Education Assistance Program
• Rewards and Recognition Program
• Parental Leave
• Employee Assistance Program
• Additional benefits such as the opportunity to leave early on Friday's,business casual dress, friendly work environment, and fun company events
  
  

Biocoat is anis 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 manager or employees.

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