BD
Senior Quality Systems Engineer (Audit and QMS)
BD, San Diego, California, United States, 92189
Job Description Summary
Develop and sustain quality system processes for the Design Center that complies with applicable regulations and standards, Corporate and Business Platform policies and procedures. Lead an effective Internal Audit Program to identify gaps in existing practices against the policies and procedures and close those gaps.
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 Develop, modify and maintain quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements
Implement Corporate and Business level Quality System procedures for the design center locations
Lead or facilitate internal quality system audits per the procedural requirements
Lead or facilitate MDSAP program
Lead the management of corporate internal and external audits
Lead the development of content for the management review process
Update and report on monthly quality metrics
Provide inputs on revisions to Corporate and Business level procedures as necessary
Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements
Lead or facilitate CAPA – Root cause investigation and implementation of corrective/ preventive actions as it pertains to QMS
Scope of Responsibilities Considered as a Subject Matter Expert for QMS processes
Work is performed without appreciable direction
Determine and pursue course of action necessary to obtain desired results
Required Qualifications: Bachelor’s degree in Science or related discipline or a combination of Associate Degree and 8 years of experience.
Minimum 5 years experience developing and sustaining quality systems for medical devices, including leading Internal and External Audits
Preferred Qualifications: ISO 13485 Lead Auditor Certification
Experience within a QMS that transitioned to MDSAP program
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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. Required Skills Optional Skills . Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
USA CA – Brea
Work Shift
NA (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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $99,000.00 - $163,300.00 USD Annual
Develop and sustain quality system processes for the Design Center that complies with applicable regulations and standards, Corporate and Business Platform policies and procedures. Lead an effective Internal Audit Program to identify gaps in existing practices against the policies and procedures and close those gaps.
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 Develop, modify and maintain quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements
Implement Corporate and Business level Quality System procedures for the design center locations
Lead or facilitate internal quality system audits per the procedural requirements
Lead or facilitate MDSAP program
Lead the management of corporate internal and external audits
Lead the development of content for the management review process
Update and report on monthly quality metrics
Provide inputs on revisions to Corporate and Business level procedures as necessary
Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements
Lead or facilitate CAPA – Root cause investigation and implementation of corrective/ preventive actions as it pertains to QMS
Scope of Responsibilities Considered as a Subject Matter Expert for QMS processes
Work is performed without appreciable direction
Determine and pursue course of action necessary to obtain desired results
Required Qualifications: Bachelor’s degree in Science or related discipline or a combination of Associate Degree and 8 years of experience.
Minimum 5 years experience developing and sustaining quality systems for medical devices, including leading Internal and External Audits
Preferred Qualifications: ISO 13485 Lead Auditor Certification
Experience within a QMS that transitioned to MDSAP program
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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. Required Skills Optional Skills . Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
USA CA – Brea
Work Shift
NA (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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $99,000.00 - $163,300.00 USD Annual