Job Description

Ideal candidates will have extensive experience in FDA, AATB and other applicable regulations and standards.

LHH Recruitment Solutions has Quality Control Manager opening for our client in the Conshohocken, PA area. This direct hire role allows you to collaborate with numerous departments to facilitate quality control and process improvement as well as strategic sourcing. This on-site position requires a bachelor’s degree in Biological Science or similar, and 5+ years in a medical device manufacturing Quality Control Manager role. Ideal candidates will have extensive experience in FDA, AATB and other applicable regulations and standards.

Salary range: $80,000 to $90,000

RESPONSIBILITIES :

• Oversee the planning, directing, and/or coordinating quality programs, quality control, within laboratory and production efforts in a manufacturing environment.
• Maintain a constant working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations and industry standards
• Create, revise and implement procedures/controlled documents according to FDA, AATB, and other applicable regulations as needed.
• Manage and oversee inspection of HCT/Ps and medical devices.
• Define, sort, and document acceptable and unacceptable HCT/P products and/or medical devices.
• Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures
• Analyze test results and testing procedures to provide feedback and interpretation to management.
• Create, implement and present reports regarding any issues of products or processes, daily production quality, quality trends.
• Directly manage investigations of incidents related to quality to solve root cause.
• Manage customer complaints, investigations, and review.
• Provide technical expertise as needed – SME status.
• Create and review case studies or regulatory standards and trends to stay abreast of issues in the field of quality control and quality assurance.
• Identify critical points in the manufacturing process and specify sampling procedures to be used at these points.
• Design, implement and train and update standard operating procedures or quality assurance manuals.
• Verify raw materials. parts, in-process samples and finished products meet established testing and inspection standards.
• Instruct contractors on quality guidelines, testing policy and procedure, or ways to eliminate deficiencies.
• Define, order, and coordinate the selection and implementation of quality control equipment.
• Monitor the development of any and all new products to identify possible problems prior to mass production.
• Train others in quality control and communicate quality control information to all departments, vendors, or contractors.

REQUIREMENTS :

• Bachelor's degree in a relevant Biological Sciences or Similar and/or 5+ years manufacturing experience in medical device industry.
• Proven experience in FDA, AATB and other applicable regulations and standards.
• Proven ability to oversee multiple priorities and make sound business decisions.
• Knowledge of the practical application of engineering science and technology - applying principles, techniques, procedures, and equipment to design and production.
• Knowledge of principles and methods for training, teaching and instruction for individuals and groups.
• QMS systems experience.

Ideal candidates will have extensive experience in FDA, AATB and other applicable regulations and standards.

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