Quality Engineering Supervisor

The Quality Engineering Supervisor coordinates and supervises the preparation, scheduling, and execution of validation protocols (DQ, IQ, OQ, PQ) as well as the design of testing strategies and methodologies for the qualification, verification and validation of products, processes, equipment, and facilities in compliance with applicable requirements. Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors.

Essential Job Functions

• Own and manage product, process, equipment and facilities verification, validation and certification activities. Oversee equipment certification and calibration performance and documentation. 
• Generate and/or perform reviews of validation documentation in accordance with relevant regulations and standard operating procedures.
• Interface with Process Engineering and Development and operations to ensure that the transfer of new products and processes is in accordance with quality standards. Audit before and during startup operations to ensure compliance with appropriate validation requirements.
• Review operational procedures and ensure the directions and parameters described reflect validated conditions.
• Identify areas of improvement for validation systems/procedures and to design and implement required improvements.
• Support quality investigations resulting from nonconformance and provide CAPA support. Investigate and work to resolve validation matters which may have an adverse impact on the validation status of product, process, equipment or facilities.
• Represent company-wide quality system elements and validation strategies during internal/external and third-party audits/inspections.
• Performs other duties as assigned.

 About CBC/CTS:

• We offer a highly competitive benefits package including medical, dental, vision, life and supplemental insurance, 401(k) with employer contribution and match, and generous paid time off (PTO) - up to 5 weeks in your first year!
• CBC began in Dayton in 1964 as the region’s first centralized blood bank. CBC collects and provides all blood products for hospitals in our 15-county region and beyond. CTS was born in 1986 and is now one of the nation’s largest tissue banks. CTS recovers, processes, and distributes human tissue grafts and is the nation’s largest non-profit provider of skin grafts for burn patients.

Community Blood Center/Community Tissue Services is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.

Drug Free Workplace

MINIMUM REQUIREMENTS

 EDUCATION and/or EXPERIENCE

• Bachelor’s degree.
• Minimum of 3 years’ experience in quality control, quality assurance, clinical laboratory, blood banking, tissue banking, or pharmaceutical/other manufacturing environment.

WORK ENVIRONMENT and PHYSICAL ACTIVITIES

• Must be able to meet the required physical demands with or without reasonable accommodation.

DESIRED QUALIFICATIONS

• Bachelor’s degree in Medical Technology, Biology, Life Science, Biomedical Engineering or equivalent preferred.
• Cumulative functional experience working within the FDA regulated Medical Device, Biologics and/or Manufacturing industry.
• Knowledge of applicable regulatory requirements from AABB, AATB, FDA, OSHA & ISO.
• ASQ Certified Quality Engineer certification and/or Certified Tissue Bank Specialist (CTBS) certification.
• Experience in auditing, quality control, quality assurance, clinical laboratory, blood banking, tissue banking, or pharmaceutical/other manufacturing environment.
• Sound knowledge and understanding of GMP & GTP requirements and industry standards.
• Demonstrated ability to write complex technical reports. Strong writing and communication skills; ability to communicate effectively and negotiate as necessary at multiple levels.
• Demonstrated ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.
• Proven ability to inspire individuals and develop functional teams that commit to collectively working towards the achievement of corporate objections.
• Periodic travel may be required.