Global QMS Leader, Medical Devices & Compliance

Teleflex; Massachusetts; Hybrid; USD 153,000 - 175,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off (PTO)

Short- and long-term disability

Parental leave

Job summary

Ingenyx seeks a Senior Quality Management Systems Manager to lead and continuously improve our global medical device QMS across sites. You will govern CAPA, change control, document control, and quality metrics while overseeing supplier quality programs and internal audits.

This role requires ISO 13485 and FDA QMS expertise, with leadership to drive cross-functional initiatives, regulatory readiness, and digital QMS implementations in a fast-growing organization.

Qualifications

• Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related technical discipline.
• 10+ years Quality experience in 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.

Responsibilities

• 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 core QMS processes, including CAPA, change management, document control, training, Management Review, and quality metrics.
• Provide governance and oversight of 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 SME 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.

Skills

QMS governance

Regulatory compliance

Leadership

Auditing

Process improvement

Cross-functional teamwork

Education

Bachelor's degree in Quality/Engineering/Life Sciences/Regulatory Affairs

Tools

eQMS

ERP Quality

Job description

Ingenyx seeks a Senior Quality Management Systems Manager to lead and continuously improve our global medical device QMS across sites. You will govern CAPA, change control, document control, and quality metrics while overseeing supplier quality programs and internal audits.

This role requires ISO 13485 and FDA QMS expertise, with leadership to drive cross-functional initiatives, regulatory readiness, and digital QMS implementations in a fast-growing organization.