Job Description Summary
As directed by the Quality Manager, the Senior Quality Engineer is accountable for Quality Assurance in the manufacturing area by developing and maintaining quality control plans, dealing with non-conforming material, customer complaints, remediation projects, CAPAs and providing quality metrics to manufacturing and quality management. This position assures the manufacturing areas are compliant to medical device regulations, good manufacturing practices, and leads continuous improvement activities for improved quality and production.
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.
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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
- Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods/plans, work instructions, and raw material specifications.
- Analyze and interpret inspection and process data to identify continuous improvement opportunities and prevent quality problems.
- Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material.
- Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.
- Support manufacturing and quality process improvement projects as an effective team member or leader using continuous improvement and six sigma tools.
- Develop working knowledge of applicable regulatory, corporate and unit requirements.
- Facilitate change control, as needed.
- Conduct internal audits as required. Provide audit support for customer and regulatory audits (preparation, closure, etc.).
- Communicate across functions and departments for assigned areas of responsibility.
- Analyze and verify the consistency of existing products through annual product review.
- Perform manufacturing investigations for out-of-specification / out-of-trend investigation for product release.
- Writes and leads risk management activities.
- May perform other duties as required.
Education and Experience
This position requires:
- Bachelor's degree in engineering or a scientific field with a minimum of 3 years relevant experience or 8 years of a combination of equivalent education and relevant experience.
Preferred qualifications include:
- Leadership, project management, and sophisticated communication skills
- Automated high-volume manufacturing experience
- Extrusion process for medical devices experience (plus)
- Training in design of experiments and statistics
- Knowledge of design control principles
- Knowledge of six sigma methodology
- ASQ certified quality engineer (CQE)
- Compliance with all local, state, federal, and BD safety laws, policies, and procedures including RCRA Hazardous waste regulations.
- Compliance with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles
Knowlege and Skills
- Experience with analytical problem-solving skills, technical writing skills, automated documentation systems and root cause analysis.
- Continuous Improvement experience and Six Sigma Green Belt certification/training
- Process validation, Design of Experiment (DOE), 21 CFR 820-21/211 cGMP, ISO 13485-9001 experience.
- Strong understanding of the role of quality in an organization.
- Good Documentation Practices
- Technical Writing Skills
- Basic Computer skills
- Effective written and oral communication skills
At BD, we prioritize on-site collaboration because we believe it cultivates 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 aim 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.
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Required Skills
Good Manufacturing Practices (GMP), Process Quality Control, Quality Management, Statistics, Written Communication
Optional Skills
Continual Improvement Process, Process Improvements
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Primary Work Location
USA UT - Sandy
Additional Locations
Work Shift
US BD 1st Shift 8am-5pm (United States of America)