Senior Quality Management Systems Manager

🔥 15 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $152.8k - $175k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Teleflex

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $275k Venture Round on 2010-01

Healthcare • Manufacturing • Healthcare Insurance

Teleflex is a global provider of innovative medical devices and solutions, dedicated to supporting healthcare professionals and enhancing patient care. With a diverse portfolio that includes products for anesthesia, emergency medicine, interventional cardiology, and more, Teleflex aims to improve the health and quality of lives. The company emphasizes its commitment to education and customer support in the healthcare sector.

📋 Description

• Lead global QMS governance, harmonization, and continuous improvement across sites and functions. • Lead regulatory and standards surveillance, gap assessments, and implementation of new or revised requirements. • Provide governance of CAPA, change management, document control, training, Management Review, and quality metrics. • Govern and oversee the Supplier Quality Program, including qualification, monitoring, performance, SCARs, and supplier risk. • Lead the Internal Audit Program, including audit planning, auditor qualification, execution, reporting, and follow-up. • Lead implementation and optimization of electronic QMS and Document Control systems within the ERP/eQMS environment. • Provide Quality oversight for computer software assurance/validation of quality-impacting systems. • Drive QMS performance, inspection readiness, and continuous improvement using metrics, trends, and risk-based decision-making. • Serve as a senior QMS subject matter expert during FDA, Notified Body, MDSAP, certification, and customer audits. • Oversee quality processes supporting customer information requests and change notifications. • Lead, coach, and develop the QMS team and partner with site and functional leadership to drive Quality System effectiveness.

🎯 Requirements

• Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related technical discipline. • 10+ years of Quality experience in the medical device or regulated life sciences industry. • 5+ years leading QMS programs or major Quality System initiatives. • 5+ years of people-management experience. • Advanced knowledge of ISO 13485 and FDA medical device QMS requirements. • Experience with global regulatory requirements, regulatory/standards gap assessments, and QMS implementation. • Strong experience with core QMS processes and Supplier Quality Program governance in a manufacturing environment. • Experience with regulatory inspections, Notified Body audits, MDSAP, and/or certification audits. • Demonstrated ability to lead complex, cross-functional and multi-site initiatives. • Strong leadership, analytical, communication, technical writing, and problem-solving skills. • Global or multi-site medical device QMS experience. • Knowledge of EU MDR and medical device requirements in Canada, Australia, Brazil, Japan, Switzerland, and the UK. • Experience with eQMS/ERP Quality systems, software assurance/validation, and ISO 14971 risk management. • Lead Auditor, ASQ CMQ/OE, CQA, RAC, or equivalent certification preferred.

🏖️ Benefits

• Medical insurance • Prescription drug insurance • Dental insurance • Vision insurance • Flexible spending accounts • Participation in 401(k) savings plan • Paid time off (PTO) • Short-term disability • Long-term disability • Parental leave