
Associate Director, Quality Engineering Lead (In-Vitro Diagnostics)
Are you an experienced Quality Engineering professional with a passion for In-Vitro Diagnostics? Do you thrive in a fast-paced, dynamic environment and have a proven track record of leading successful teams? If so, Bristol-Myers Squibb has an exciting opportunity for you as our Associate Director, Quality Engineering Lead for In-Vitro Diagnostics. In this role, you will be responsible for ensuring the quality and compliance of our IVD products while leading a team of talented engineers. We are seeking a highly motivated individual with strong leadership skills and a deep understanding of IVD regulations and guidelines. If you are ready to take your career to the next level, apply now and join our team at Bristol-Myers Squibb.
- Oversee the quality and compliance of all In-Vitro Diagnostics products within the company, ensuring adherence to all relevant regulations and guidelines.
- Lead and manage a team of quality engineers, providing guidance, support, and development opportunities.
- Develop and implement quality strategies and processes to continuously improve product quality and compliance.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure timely and successful product development and commercialization.
- Conduct risk assessments and develop risk management plans to mitigate potential quality and compliance issues.
- Monitor and analyze quality data to identify trends and areas for improvement.
- Lead investigations and root cause analyses for any quality or compliance issues, implementing corrective and preventive actions as needed.
- Maintain a thorough understanding of IVD regulations and guidelines, and ensure that the team is trained and compliant.
- Represent the company in external audits and inspections related to IVD products.
- Develop and maintain relationships with external partners and suppliers to ensure quality and compliance throughout the supply chain.
- Communicate regularly with senior leadership, providing updates on quality and compliance status and any potential risks or issues.
Bachelor's Or Master's Degree In Engineering, Life Sciences, Or A Related Field.
Minimum Of 7 Years Of Experience In Quality Engineering In The In-Vitro Diagnostics Industry.
Strong Knowledge Of Fda Regulations And Iso Standards Related To In-Vitro Diagnostics.
Experience Leading And Managing A Team Of Quality Engineers.
Excellent Communication Skills And The Ability To Collaborate With Cross-Functional Teams.
Risk Management
Quality Assurance
Process Improvement
Project Management
Validation
Data Analysis
Six sigma
Quality Control
Root Cause Analysis
Compliance
Continuous Improvement
Regulatory Affairs
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Associate Director, Quality Engineering Lead (In-Vitro Diagnostics) in Summit, NJ, USA is between $160,000 and $200,000 per year. This range may vary depending on factors such as experience, qualifications, and the specific company and industry.
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Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.

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