Quality Control Manager

Proclinical is currently recruiting for a Quality Control Manager for a biopharmaceutical company located in West Lafayette, IN. Successful candidate will be responsible for developing and implementing a QMS for Class III medical devices. The Manager will lead and provide regulatory guidance, support management with regulatory program planning, and implementation of departmental strategies and policies.

Job Responsibilities:

• Lead Development and implementation and execution of the Quality Management System (QMS) to meet FDA regulations.
• Ensure accurate and current documentation.
• Address daily QMS demands to include CAPA.
• Understand scientific protocols and test procedures; confer with appropriate staff to determine quality and reliability standards.
• Write quality program documentation, including quality plans, incoming inspection instructions, and new product inspection techniques.
• Assist Purchasing Department with maintaining appropriate vendor quality.
• Communicate with internal and external vendors verbally and in writing regarding quality standards and specifications.
• Identify quality-related customer issues and develops corrective action plans.

Skills and Requirements:

• Masters or higher in a Life Science Discipline.
• Experience in a QA managerial position in the Medical Device industry.
• Experience developing a QMS.
• 3 years minimum industry experience.
• Must possess good communication and organizational skills.
• Must be able to lead a team and work independently.
• Computer experience with Windows, Excel, and Word required.
• Experience with GMP and GLP desired.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brandy Plumb at (+1) 646-367-2745 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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