Job Description Summary
Identify gaps, improve and/or further develop Quality Management System (QMS) key elements per cGMP, ISO/IEC 17025:2017 and 13485:2016. Responsible to manage and execute all areas of QMS for the site (e.g. internal audits, training, calibration, document control, records management, CAPA, Deviation, Management of Change, OOS).
Ensuring timely and effective implementation of all company's policies, procedures, and activities involved in assuring the quality of products and services.
Maintains close working relationships with other department Managers and supervisory personnel in order to meet and maintain product/service quality, identify, solve and prevent problems affecting product/service quality, maximize productivity, and comply with regulatory requirements.
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.
Responsibilities
Identify gaps and opportunities to further develop QMS including writing and implementing SOPs and work instructions.
Identify and Implement solutions in cooperation with other QA department personnel to improve quality and work efficiency.
Schedule and hosts client and regulatory audits.
Report all audit findings to upper management and respond to audit reports.
Maintain compliance to site Validation Master Plan by working with QA Management and site Operations Management.
Maintain implemented programs (GMPs, Pest Control, Equipment Calibration, etc.) to ensure compliance by all employees and other personnel in the facility.
Carry out the company’s Quality Assurance System for the completion of testing services in accordance with client specifications, the company’s standard operating procedures, and regulatory agencies regulations.
Critically review and coordinate timely QA review and approval of project documentation including protocols, raw data, and associated reports to ensure accuracy of all information.
Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments and lead compliance for the site.
Perform review and trending of all Quality Events including Client Complaints, Out of Specification results and Non-conformances/Deviations and Corrective and Preventive actions.
Develop, train and mentor staff to by sharing knowledge, skills and information with personnel in the Quality Assurance Department and across functional areas.
Manage and execute site Quality System elements and processes such as CAPA, Deviations, OOS, Management of Change, ensuring that they are completed on-time and properly documented.
Provide site training and maintain a working knowledge of cGMP, ISO and other relevant regulatory guidelines to act as a resource of information for site personnel.
Oversee and/or perform all site QA document control/administrative tasks.
Ensure that Standard Operating Procedures are being followed.
Assist with issuance, review, revisions, and archiving of all quality documents.
Manage the internal audit program.
Work closely and communicate openly with Quality Management.
Reports to the Quality Assurance Director.
Communicates daily with Site Operations Management and Technology Development Management to provide QA support and understand project deadlines.
Qualifications
A college degree is required with a major in a relevant scientific field. Quality Assurance or Quality Control cGMP (21 CFR Part 820) experience is a must (> 8 years). Relevant work experience in a testing laboratory or medical device knowledge is preferable.
Knowledge of ISO 13485, ISO/IEC 17025 is a plus.
Ability to work under pressure (in a fast-paced environment), meet deadlines (overtime if work requires it) and make effective decisions.
Ability to adapt to changing organizational and operational needs; ability to lead others through change.
Ability to handle multiple tasks simultaneously.
Strong professional skill in organization and prioritization, and attention to details.
Strong team player and leader with the ability to work across multiple functions and disciplines.
Must be able to effectively communicate ideas (verbally and in writing), be a self-starter and handle difficult situations.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN
Primary Work Location
USA CA Temecula
Additional Locations
Work Shift
US BD 1st Shift 8am-5pm (United States of America)
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
Salary Range Information
$121,100.00 - $199,800.00
