INGENYX- Senior Quality Management Systems Manager

Position Summary

We are seeking an experienced Senior Quality Management Systems (QMS) Manager to lead and continuously improve our global medical device Quality Management System.
This role provides leadership for QMS governance, regulatory and standards compliance, Supplier Quality, internal audits, digital Quality Systems, and continuous improvement across multiple sites. The ideal candidate combines strong medical device QMS expertise with regulatory judgment, people leadership, and the ability to drive change across a global organization.

Principal 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.

Education / Experience 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.

Specialized Skills / Other Requirements

What Success Looks Like

You will build and sustain a compliant, effective, inspection-ready global QMS, strengthen Supplier Quality and digital Quality Systems, anticipate regulatory changes, and drive consistent execution and continuous improvement across the organization.

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The pay range for this position at commencement of employment is expected to be between $152,800- $175,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.