Quality Control Specialist - LHH : Job Details

LHH Recruitment Solutions has Quality Control Specialist 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. This on-site position requires a bachelor's degree in Biological Science or similar, and 1+ years in a medical device manufacturing role. Ideal candidates will have experience in FDA, AATB and other applicable regulations and standards.

Salary range: $25.00 - $28.00 per hour

RESPONSIBILITIES:

• Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements. Per organization, FDA and AATB.
• Define, sort, and document acceptable and unacceptable HCT/P products and/or medical devices.
• Prepare, create and document shipping documents and packages in accordance with standard operating procedures.
• Maintain a constant working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations and industry standards
• Communicate and escalate inspection or quality control issues to management/Quality Control as necessary.
• Initiate, review and document quality control records to include environmental monitoring, and HCT/P inspection.
• Support and collaborate on internal and external audits.
• File and maintain records in accordance with standard operating procedures and regulations and recordkeeping.
• Create, implement and present reports regarding any issues of products or processes, daily production quality, quality trends.
• Create and review case studies or regulatory standards and trends to stay abreast of issues in the field of quality control and quality assurance.

REQUIREMENTS:

• Bachelor's degree in a relevant Biological Sciences or Similar and 1+ 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.
• QMS systems experience highly preferred.