Staff Quality Engineer (Post Market)
BD
USA CA - San Diego Bldg A&B, Unknown
Full-Time
$124,700
OfficeSenior
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.
The Senior Quality Engineer will ensure the timely completion of design control (including risk management) deliverables in support of pre-release activities and will execute post-market activities.
Roles and Responsibilities:
Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.
Engage in design and development and post-market activities for both medical and non-medical
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Design Quality Engineer members that share in varying pieces of the risk management lifecycle
Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.
Find opportunities for continuous improvement of the Risk Management Process
Required Qualifications:
Bachelor’s degree in engineering field and 5 years of Quality, Design Controls, Risk Management experience within the medical device industry
Minimum of 5 years of Post-Market Quality, specifically complaint trending/data analytics.
Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies
Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971 and ISO 13485.
The position requires strong oral and written communication and interpersonal skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products
Preferred Qualifications:
Experience with Hazard Analysis or FMEA and verification/validation
Quality certifications relevant to BD, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
Required Skills
Optional Skills
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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
$124,700.00 - $205,800.00 USD Annual