BD · 4 hours ago
Senior Quality Engineer (Instrument Plant)
Sparks, MD
Full-time
Onsite
Mid, Senior Level
$93K/yr - $153K/yr
5+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a Senior Quality Engineer to ensure compliance with quality systems and regulations in the Instrument Plant. The role involves leading projects, managing quality standards, and supporting continuous improvement initiatives in product and process quality.
Health CareMedical DeviceTechnical Support
Responsibilities
Initiates and/or supports CAPAs and may lead the investigation/corrective action process
Responsible for the various aspects of ID/AST plant sustaining, validation, & NPD Quality Engineering, including routine Quality Engineering responsibilities for assigned ID/AST products and quality system focus
Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to the product line. This includes assuring departmental compliance with ISO, IVDR and FDA requirements through supporting internal and external audits, participation on various cross-functional project teams, assigned project support, product launches, process improvements, and coordination/resolution of CAPAs, quality notifications, supplier management and change notifications
Uses tools for risk analysis/management, 8D, validation, and project management, sampling plans, Six Sigma, control plans, design control and trending
Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes, and verifies effectiveness of changes
Develops and maintains efficient methods for regularly reporting status to management the product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements
Qualification
Required
Bachelor's Degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field with minimum of 5 years' experience within the quality function or Master's Degree with minimum of 3 years' experience in quality
Experience handling multiple projects simultaneously in a fast-paced environment
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required
Preferred
Pharma/Medical device industry experience preferred
Experience with Minitab or other statistical analysis platforms preferred
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ 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
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Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
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