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BD · 2 days ago
Senior Quality Engineer
Durham, NC
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Consistent application of quality engineering principles (e.g. acceptance sampling, statistical process control, measurement/test methods, quality planning, failure investigation, design of experiments, process FMEA, value stream mapping, hypothesis testing, descriptive statistics, process capability)
Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
Develops validation protocols based on business and operations needs. Ensure product development and validation programs meet requirements of FDA and ISO when applicable.
Leads execution of non-conforming material (Quality Notification) process per company procedures, ensuring approaches result in effective control and efficient operations.
Proven problem solving skills. Leads CAPAs related to area of responsibility.
Makes measurable improvements to BD processes and procedures
Evaluates the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training)
Lead moderately complex risk management activities including risk management reviews, risk analysis, updating/maintaining process hazard analysis, and presenting to Risk Management board.
Ensures that all sustaining design change control and production / process control projects meet applicable regulatory (local and international), Corporate, and Segment requirements
Qualification
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Required
Bachelor’s Degree in Mechanical Engineering, Electrical Engineering or related field, or work experience in lieu of completed degree
5+ years of relevant work experience combined with Process Engineering, Quality Engineering and Lean Manufacturing fields
Results orientated with strong written and oral communication skills to lead multi-functional teams are required.
CA/PA experience - Candidate must have owned and completed a CA/PA successfully.
Strong understanding of GD&T, Process Capability (Cpk), Statistical Process Control (SPC) and apply these principles to receiving incoming Inspections (external suppliers), internal (suppliers) manufacturing operations
Experience with GR&R studies and metrology equipment, such as solid understanding of CMM, calipers, height gages, dial indicators, and micrometers
Experience training operators on new quality procedures
Strong supplier management background to include supplier audits, part approval, supplier score cards, corrective actions, MRB-RTV disposition, and Field Failure Analysis follow up with suppliers
Experience implementing Lean disciplines and 5-S to internal processes, particularly in inventory management and handling of expensive components into storage or kitting to production line
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10,001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (48)
2022 (142)
2021 (217)
2020 (149)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
Leadership Team
Tom Polen
Chairman, CEO and President
Philippe Francois
Senior Vice President, Global Supply Chain
Recent News
2024-06-04
Business Wire
2024-06-03
Company data provided by crunchbase
