Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Summary

The Quality Assurance Manager, Quality Engineering is accountable for sustaining and supporting all BDB San Diego reagents and assay manufacturing operations.  Owns, tracks and reports on the non-conforming materials, deviation, Global Hold, and Material Review Board processes in accordance with the existing policy, procedures, and standards.  Applies project management skills to lead cross-functional and interdepartmental investigations and ensures quality issues are closed with effective solutions.  Possess in-depth knowledge of Good Manufacturing Practices (GMP) and Quality Engineering Principals to site’s Operations team.  This role will also provide support during the design transfer or design change.

People Management:
1.    Mentors and develops team members, including succession planning.   
2.    Focuses on employee engagement activities including development and retention, while also responsible for carrying out hiring, job assignments, termination recommendations, transfers, promotions, salary actions, and performance reviews on time.
3.    Motivates and develops junior staff
4.    Acts as advisor and coach to subordinates to meet schedules and resolve technical problems. 
5.    Ensures effective conflict resolution among team members to maintain team’s cohesiveness while ensuring alignment of team to business goals.
6.    Develops and administers work schedules and provides management with updates on work assignment, quality metrics, and or quality issues.   
7.    Identifies and works through obstacles that may hinder associates from focusing on and delivering their individual impact goals.
8.    Ensures the functional quality organization fulfills its obligations and complies with applicable regulations and procedures.
9.    Effectively navigates and leads through the challenges of change and establish key stakeholder engagement focused on win-win solutions.
10.    Continuously evaluate progress toward tactical goals and objectives adapting them to meet customer and business needs
11.    Manages customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
12.    Maintains positive and cooperative communication and collaboration with all levels of employees, customer, contractors, and vendors.

Functional responsibilities:
1.    Oversees the Sustaining Quality Engineering team and process for BDB-San Diego and provides guidance to ensure that activities are performed in accordance with Quality Systems and Regulatory requirements. Ensure compliance to Quality System Requirement, such as ISO standards ISO 9001 and ISO 13485 requirements.
2.    Leads the Product Realization – Control of Nonconforming Products and Material Review Board process
3.    Effective use root cause analysis, application of technical principles, quality tools, and quality systems.
4.    Uses process and quality control statistical methods to identify and correct or support the continuous improvement of QMS and production processes
5.    Gather, evaluate, analyze, and present quality metric results (i.e.: Quality Notification, Targeted QN trending, Total NC trending) to identify leading indicators of issues.  
6.    Drive quality improvements to address these leading indicators, complaints, nonconformances, CAPA.  Collaborates and works with a cross-functional matrix environment to implement continuous improvements.
7.    Follow up to ensure results are translated into updates to Risk Management File documentation.

Requirements:

• Minimum of a B.S. in science, engineering, or other relevant discipline, with a minimum of 5 years relevant technical experience within medical, pharmaceutical or Life Science industry.

•  Minimum of 5 years’ experience in people leading role.

• Knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. ISO 9001, ISO 13