Senior Quality Engineer (Instrument Plant) jobs in United States
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BD (Tissuemed Ltd) · 1 day ago

Senior Quality Engineer (Instrument Plant)

positionSparks, MD
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$93K/yr - $153K/yr
date5+ years exp

BD 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 documentation for their Instrument Plant. The role involves leading projects, assessing quality parameters, and driving continuous improvement initiatives.

Health CareHospitalMedicalMedical Device

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

Quality Systems complianceRisk analysis/managementStatistical analysis (Minitab)ISO complianceContinuous ImprovementMicrosoft OfficePharma/Medical device experienceProject management

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 (Tissuemed Ltd)

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Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
dateFounded in 1985
location
Leeds, Leeds, GBR
people-size11-50 employees
web-link
http://www.tissuemed.com/

Funding

Current Stage
Early Stage
Total Funding
$0.05M
2021-12-09Acquired
2015-06-01Grant· $0.05M

Recent News

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2025-02-21
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