BD (Becton, Dickinson and Company) Sr. Quality Engineer in Louisville, Colorado
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Sr. Quality Engineer is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate voluntary standards, and BD policies and procedures. This position will work as a member of a TTM cross-functional project team engaged in ongoing Product Life Cycle technical support. Will serve as a quality representative on project core teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution. This position requires a self-directed individual able to prioritize different projects and tasks utilizing a high level of written and oral communication skills. In addition the incumbent may be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of Sustaining Engineering and/or New Product Development projects, and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities.
Essential duties and responsibilities
Participates on Project Teams as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
Lead Quality Initiatives for Target Temperature Management products that include the entire product life cycle (Development, Commercialization and Post Market Surveillance)
Creates reviews and approves Risk Management Files documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s
Leadership in failure investigations, corrective and preventive actions plan and continuous improvement projects using methodologies as Six Sigma/Lean Six Sigma.
Creates, reviews, and approves Design Specifications, Design Verification Protocols and reports, Process and Product Validations, Software Validation documents and Test Method Validations
Creates, reviews, and improves Quality System Documents (CAPA, Audits, Risk Management, Design Control))
Drives Reliability planning and Quality Planning for New Product Development.
Other duties as assigned
Extensive knowledge of Medical Device standards and regulations including ISO 13485, ISO 14971, FDA regulations QSR, IEC 60601-1 including particular and collateral standards, IEC 62304 Medical device software life cycle and IEC 62366 Usability
Experience in Design Controls for Electromechanical Medical Devices and Disposables including design transfer to manufacturing, experience should include Risk Management and Reliability Engineering
Ability to understand Medical Devices Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
Expertise in Design Verification, Design Validation Process, Test Method and Software Validation for Medical Devices
Understands applied statistics concepts for Quality and Reliability, statistical sampling plans, statistical process control and advanced statistical methodologies such as DOE.
Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership technique, time management, project management methodologies and able to balance multiple task assignments
Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
EDUCATION and/or EXPERIENCE
B.S. in Engineering, Engineering Technology, Science or related field a minimum.
Minimum 7 years of proven experience with FDA regulated industry including 3 years on product development programs.
1 - 2 years’ experience with electromechanical devices
American Society of Quality (ASQ) certification (CQE, CRE, CQM, etc.), preferred
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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”. The anticipated compensation range for this position is $ 81,300.00 - $134,100.00 USD Annual and the compensation offered will depend on the candidate’s qualifications.
*BD follows the Pay Transparency and non-discrimination provisions described by the Colorado Department of Labor and Employment (CDLE).
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.
Primary Work Location
USA CO - Louisville