Senior Quality Engineer
Job Description SummaryBe 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 primary purpose of this position is to ensure that product designs and the processes for manufacturing them meet all BD and regulatory requirements with respect to safety and efficacy. Emphasis of this position will be to manage activities related to the EU MDR program for the Pleural and Peritoneal Access (PPA) franchise. Expected to be an active team member and cross-functional collaborator on new product development and change control project teams for medical devices; be an active team member for investigating post-production trends and/or other quality issues. The individual is responsible for supporting the Unit Quality/Design Assurance function within the Pleural and Peritoneal Access (PPA) platform. The individual maintains communication with the Unit Quality Manager for assistance in resolving major quality initiatives/projects and executing design, development, and design transfer initiatives.
The individual must be able to work under general direction to exercise judgment within generally defined practices and policies in selecting methods and techniques for acquiring solutions to problems with broad scope and complexity. The individual will work closely manufacturing plant management as well as other functions (e.g. Regulatory Affairs, Research and Development, Sustaining Engineering, Manufacturing Quality, Operations, Sterility Assurance, Packaging, Sales, Marketing, Finance etc.). The individual interacts with:
Research and Development and Product Engineering regarding quality planning and project execution that will have significant impact on the business. (i.e. new product design and development, design change, change management)
Regulatory Affairs and Quality Systems regarding new regulations and standards as they apply to regulatory submissions and managing certain quality procedures.
Designated Complaint Handling Unit (DCHU) on complaint handling/resolution, situational analysis, and risk management pre-/post- product launch
Packaging Technology Center on new product packaging projects
Sterility Assurance on sterilization process (re)validations, standards and new product design applicability to the proper sterilization cycle and/or modality
Business Unit Management regarding new product design and development as well as design transfer activities.
The individual reports directly to the Unit Quality Manager for the business unit. The individual works cross-functionally with business unit management, as well as their respective teams on matters related to new product design, design transfer, risk management, process/product design, and quality improvement projects & plans.
The major activities of the individual are:
Gap Analysis and remediation of Technical Files, Design History Files, Risk Management Files, and Quality System procedures for EU MDR compliance.
Design Assurance: Quality Planning (i.e. new product development, design excellence, and design transfer). Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements
Design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file maintenance.
Champions and drives Lifecycle Risk Management throughout the business unit
Design risk management: Assure that appropriate risk management tools (i.e. FMEA’s) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices.
Design control excellence: Continuous monitoring and improvement of the design control program/process to ensure best-in-class processes.
Change control: Ensure change control projects are comprehensively evaluated and executed per the change control process.
Regulatory compliance: Regulatory compliance projects/initiatives, as assigned, in accordance with FDA QSR’s (21 CFR Part 820), ISO 13485, CMDR, MDD/EU MDR, J-PAL and ISO 14971.
Supplier audits: Evaluation of new suppliers to support design and development and to drive supplier improvement efforts.
CAPA: Initiating and directing corrective and preventive actions to problems/issues relating to process and/or product quality, such as complaint resolution, customer interface, and regulatory action.
Inspection/Audit coordination: Assisting the BU and Plant Management Representatives in preparation for third party audits (i.e. FDA inspections, notified body audits) and in the effective closure of findings resulting from such audits.
May provide guidance and work direction to junior quality engineers
Some travel may be required.
The effectiveness of this position can be measured by the health state of Unit Quality Assurance (e.g. successful new product design launches) and critical activities/projects, as assigned, that contribute to the success of the business.
Bachelor of Science degree in Engineering from an accredited four (4) year university required. An alternate bachelor’s degree with relevant quality/engineering experience may be considered.
Minimum of 2 years of experience in one or more of the following areas: Quality Engineer in the medical device field, design assurance quality support, medical device manufacturing and design, medical device validation, risk management activities, regulatory compliance, statistics and sampling methods, and CAPA root cause analysis.
Consistent application of technical principles, theories, concepts and quality sciences / tools, Proven problem solving skills, Project management & people skills, excellent verbal & written communication skills, strong multi-task & situational management, personal & group leadership, strong interpersonal skills, excellent computer skills, system management, strong results orientation, and ability to thrive in a fast paced, improvement oriented business. Strong in the application of statistics.
Strong familiarity with regulatory requirements (FDA 21CFR820, ISO 13485, CMDR, MDD/EU MDR, and J-PAL), particularly Design control and Risk Management (ISO14971).
Statistical software (Minitab) knowledge and Six Sigma Methodology a plus.
ASQ Certification(s) (e.g. Quality Engineering/Auditing) preferred.
Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. 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 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/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminateon the basis ofrace, 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 LocationUSA IL - Vernon Hills
Additional LocationsUSA AZ - Tempe Headquarters
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Approbationdu Présiden et Chef de la direction
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