Quality Assurance Manager Conshohocken, Pa

Quality Assurance Manager Conshohocken, PA
The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards. Ideally, the incoming Quality assurance Manager has excellent leadership & management skills, is organized with great attention to detail, stellar verbal/written communication skills, great analytical thinking skills and can multitask. Must have at least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility/experience.
Duties & Responsibilities:

• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.
• Author, revise, and maintain procedures/controlled documents according to FDA, AATB, and other applicable regulations.
• Manage deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations.
• Ensure adequacy of investigations with respect to root cause analysis and CAPA assessment (as appropriate).
• Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics.
• Manage and oversee review of HCT/P donor records for final product release in accordance with standard operating procedures and regulatory/accrediting agency requirements.
• Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections.
• Assist with training of processes and corrective actions relating to quality.
• Support implementation of new projects/product development.
• Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices.
• Review and approve validation/verification protocols, execution data, and summary reports.
• Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures.
• Maintain professional working relationships with customers, partners, and vendors.
• Manage direct reports and monitor individual performance.
• Maintain records in accordance with standard operating procedures.
• Attend/participate in offsite business meetings/conferences.
• Perform other related duties as assigned.

Education & Experience:

• Bachelor’s degree in a biological science or related field required.
• At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility/experience

Salary:

• $85K

Benefits:

• 401(k)
• Health insurance
• Dental insurance
• Vision insurance
• Paid time off

Ready to join a fast growing, supportive team in an excellent working environment? We need an organized team player with a great attitude to do whatever needs to get done! We offer competitive pay with great benefits and the chance to grow with us! If you are interested, please contact us. We look forward to hearing from you. 
HCRC Staffing
 

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