BD (Tissuemed Ltd) · 1 month ago
Quality Systems Engineer 2
Zelienople, PA
Full-time
Onsite
Mid Level
3+ years expBD is one of the largest global medical technology companies in the world, committed to advancing the world of health. The Quality Systems Engineer will play a crucial role in maintaining and improving the Quality Management System to ensure compliance with regulatory standards, while also leading initiatives for continuous improvement and cross-functional collaboration.
Health CareHospitalMedicalMedical Device
No H1B
Responsibilities
Maintain and continuously improve core QMS processes including CAPA, Change Control, Document Control, Training, and Management Review
Serve as a subject matter expert (SME) for Quality System processes, providing guidance to multi-functional teams
Develop, implement, and maintain key performance indicators (KPIs) and quality metrics to drive visibility and continuous improvement
Prepare and present QMS performance data for Management Review and other quality forums
Lead the end-to-end CAPA process, including root cause analysis, effectiveness checks, and closure
Facilitate CAPA Review Board meetings, ensuring timely and effective decision-making and documentation
Partner with functional leaders to drive accountability and effectiveness in corrective and preventive actions
Oversee the Change Control process to ensure effective evaluation, risk assessment, and implementation of changes
Define and implement standard processes and training to strengthen change governance multi-functionalonal engagement
Find opportunities to streamline QMS processes, improve compliance efficiency, and enhance usability of quality systems
Support internal audits and regulatory inspections as a process owner or SME
Contribute to the development and rollout of digital tools or automation supporting QMS improvements
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related technical field required
3 years of experience in Quality Systems or Quality Engineering within the medical device, diagnostics, or other regulated industry
Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
Demonstrated experience leading CAPA programs and Change Control systems
Proven ability to develop and interpret quality metrics and drive performance improvement
Excellent communication, facilitation, and multi-functional collaboration skills
Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment visa at this time
Preferred
Proficiency with electronic quality management systems (eQMS)
Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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