BD (Becton, Dickinson and Company) Quality Engineer II 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 Quality Engineer II is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate 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.
Duties and Responsibilities:
Participates on Project Team 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 File documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s
Creates Design Specifications, Design Verification Protocols and reports, Process and Product Validations, Software Validation documents and Test Method Validations
Leadership in failure investigations, corrective and preventive actions plan and continuous improvement projects using methodologies as Six Sigma/Lean Six Sigma.
Creates, reviews and improves Quality System Documents (CAPA, Audits, Risk Management, Design controls).
Creates and reviews Product Documents.
Participates in Internal, External and Supplier Quality Audits.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 Devices and disposables, including Risk Management, Design Verification, Design Validation, Test Method Validation.
Knowledge of manufacturing processes.
Ability to understand Medical Devices Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
Understands applied statistics concepts for Quality and Reliability, statistical sampling plans, statistical process control and advanced statistical methodologies such as DOE.
Education and Experience:
B.S. in Engineering, Engineering Technology, Science a minimum.
Minimum 3 years of proven ability with FDA regulated industry, preferably on product development programs
American Society of Quality (ASQ) certification (CQE, CQA, 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