Gentell, Inc. is a manufacturer and distributor of medical devices, OTC drugs and skin care products headquartered in Bristol, PA. We are a market leader providing advanced wound care products to the long-term care industry. You would be joining a team dedicated to “making it better” every day.
About the Position:
We have an exciting opportunity for an experienced quality manager to run and maintain the company’s quality program for compliance with medical device standards and regulations. This position has a critical role within the organization and is responsible for working with the product development, production, marketing and sales teams to ensure quality products are produced in accordance with company and legal/regulatory requirements.
The ideal candidate will have relevant quality management experience, regulatory affairs experience, computer skills and a tremendous attention to detail.
Responsibilities:
- Leading the company’s quality program
- Managing and maintaining quality controls and documentation
- Developing and monitoring adherence to Process Validation Plan (IQ, OQ,PQ)
- Developing and monitoring adherence to SOPs
- Maintaining and organizing the company’s internal and external quality audit program
- Managing corrective and preventive action plans
- Maintaining all regulatory files, including but not limited to, 510(k) submissions, establishment registration, device listings, ISO certification, CE certification, regulatory inspection files, and other regulatory communication
- Ensuring compliance with national and international regulations and laws
- Provide regulatory guidance, review and approval for marketing collateral and labeling taking into account regulations, standards, and cleared product claims
Requirements:
- Bachelor’s degree in related field
- 5+ years’ quality management experience
- Experience preparing and submitting materials for 510(k) and CE Marks
- Knowledge of pharmaceutical/medical device regulations, cGMP Guidelines, ISO 13485, 21CFR820, 21CFR Part 210 & 211
- RAC Certification a plus
- Ability to work with standard Windows PC and Microsoft Office applications
We offer a pleasant working environment, competitive salary, benefits package including company-paid health insurance for the employee, and 401K with company match. We are a drug and smoke free workplace.
Job Type: Full-time
Experience:
- quality management in the medical device industry: 3 years (Required)
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