QC Supervisor

Becton Dickinson Medical Devices•San Diego, CA

14d•Onsite

About The Position

Quality Control (QC) Supervisor is responsible for leading the day-to-day activities of the QC team. The supervisor should have a thorough knowledge of the various quality control processes including QC testing assays, equipment and consumables management, and people management. The QC Supervisor is accountable for scheduling day-to-day productivity to support operation activities, associate training, review and approval of new documents and change requests. Supervisor will collaborate with the Manager to determine staffing requirements and make appropriate recommendations. Other responsibilities include: developing and implementing new or revised departmental policies and processes, preparing monthly reports, and initiating, leading, and supporting continuous improvement projects. The QC Supervisor is also responsible for written performance reviews and assisting in the career development of his/her direct reports. 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.

Requirements

Minimum of a BA/BS Degree in science, engineering, or other relevant discipline, with a minimum of six years relevant technical experience within medical, pharmaceutical or Life Science industry.
A minimum of 6 years' experience in related aspects of quality, manufacturing or production processes is necessary.
A minimum of 2-year managerial experience required, or equivalent experience in leading projects.
Knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. ISO 9001, ISO 13485) as it relates to the design and continued support of BD products.
Can develop strategy, plan projects, and drive the completion of long-term goals and objectives.
Able to use judgement to influence within and across functions to drive impact on the business/function.
Demonstrated ability to exercise independent judgement by utilizing strong analytical and tactical skills supported by facts and data.
Ability to effectively work with peers.
Effective communication (written, verbal and listening) and prioritization skills, with special attention to detail, while maintaining overall perspectives.
Prior project management is highly desirable.

Nice To Haves

Experience in immunology is a plus.
TrackWise, SAP, technical writing, auditing experience preferred.
Advanced proficiency in data analysis tools such as Excel or MiniTab preferred.

Responsibilities

Manage departmental work schedule to ensure timely and effective execution of all QC testing and daily operational objectives.
Participate in the development and initiation of business strategies for the QC department to meet the goals and objectives of the business including staffing, equipment and space requirements.
Proficient in prioritization of group workload and assignment of testing, communicates effectively with other departments on status updates.
Create and prepare daily/weekly/monthly reports to include required corporate metrics, project timelines and productivity measurements.
Develop and implement new or revise current department policies and procedures including departmental SOPs and Batch Records for all QC functions.
Review and approve all required documentation, including QC Batch Records, change notifications and SOPs.
Perform, maintain and document routine training program for departmental employees.
Lead human resource management requirements including the interviewing, hiring, and training of all departmental Associates as well as preparation and review of departmental employee annual performance appraisals, goal assignments and career development planning.
Direct departmental projects and initiatives to include cost savings and process optimization directives and process improvements.
Initiate and lead the departmental continuous improvement programs (i.e. Lean, Six Sigma, etc.) by providing the tools, resources and support needed.
Participate in the development and optimization of manufacturing processes and procedures to optimize departmental efficiencies and maintain good product quality.
Responsible for equipment and supplies ordering, including new equipment onboarding activities, test method development, and/or validation support including protocol/report writing.
Oversee equipment calibration, equipment logs and required documentation as necessary.
Work with instrumentation department for onboarding and troubleshooting of equipment.
Manage inventories of reference materials or other assay standards including supplies and reagents used in QC assays.
Ensure a high level of customer service to all internal and external customers including responsiveness and clearly managing expectations.
Receives minimal direction on routine work, general instructions on new assignments, issue resolution, projects, and other assignments.
Additional responsibilities may be evaluated and/or added, based on business and quality needs.
Performs other tasks assigned by management as required.
Implements the company’s Affirmative Action Plan as it applies to the function supervised.
Monitors conduct and relationships among the associates supervised to prevent discriminatory acts or comments.
Keeps abreast of U.S. and non-U.S. regulations affecting own area of supervision / management and complies with those regulations, practices and procedures to support regulatory compliance requirements.
Communicates the need for compliance to members of own functional area.
Brings regulatory compliance questions/issues to the attention of the next level of management.
Ensures Environmental Health and Safety (EH&S) training through facilitating the development and implementation of safety awareness programs.