Senior Quality Engineer

Responsibilities

• Provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and industry standards.
• Support new product development and existing product sustaining activities to ensure work follows proper design
• control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development
• teams and identifying Quality needs, product improvements and customer requirements.
• Ensures adequate design control documentation and records are maintained to support life cycle of design history.
• Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an
• acceptable quality level during manufacturing with properly established product specifications.
• Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.
• Review and authorize Quality approval for new product and/or device design specifications including product
• performance specifications, test methods, acceptance criteria, and release.
• Support product and/or device continuous improvement initiatives by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.
• Review and assess work performed by R&D and other BD business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
• Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and
• Process Validation.
• Lead or participate in ISO 14971 Risk Management activities appropriate to the initiative or situation.
• Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customer
• input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with
• Manufacturing, Service, Engineering, Regulatory and Biostatics.
• Initiate Corrective and Preventative Action plans and perform efficacy follow up.
• Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and
• regulatory requirements.
• Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs
• and established Quality Systems.
• Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries.
• Support regulatory inspections as needed.
• Support activities relating to Field Corrective Actions, when needed.
• Provide guidance quality and training to other quality engineer to help increase knowledge of regulations and
• standards for Devices and Combination Products.
• Support remediation and regulatory requirements including MDSAP/EUMDR.
• Required Qualifications:
• Bachelor's degree in STEM and five (5) years of engineering experience within a regulated industry, OR
• Master's degree in STEM and four (4) years of engineering experience within a regulated industry

Requirements

• American Society of Quality (ASQ) certification (CQE, CQA, etc)
• Experience in medical device industry
• Knowledge and Skills:
• Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills .

Benefits

Additional Information

We are the people who give possibilities purpose 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. Job Description The Sr. Quality Engineer is accountable for quality support for devices, products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes.

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