Senior Manager – Global Quality Systems

Job not on LinkedIn

🕒 2 days ago

🦌 Connecticut – Remote

🦌 Connecticut – Remote

💵 $140.5k - $200.7k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 5%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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CooperCompanies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1978

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Post-IPO Equity on 2021-12

Healthcare • Consulting • Food & Beverage

CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.

📋 Description

• Support the governance, effectiveness, and continuous improvement of the global QMS • Drive harmonization, compliance, and operational excellence across global quality system processes • Partner with process owners and cross-functional stakeholders to identify and mitigate quality system risks and ensure inspection readiness • Lead the global Management Review program, including planning, reporting, action tracking, and continuous improvement • Develop and maintain quality system KPIs, dashboards, and performance reporting • Prepare executive-level reporting on QMS health, quality objectives, risks, and improvement opportunities • Monitor process effectiveness and drive improvements that enhance compliance, efficiency, and user experience • Monitor evolving global regulations, standards, guidance documents, and industry best practices • Lead quality system impact assessments and gap analyses • Develop and track implementation plans for regulatory and standards requirements • Partner with Regulatory Affairs and Quality leadership to evaluate regulatory requirements • Lead Quality Systems due diligence, integration planning, and QMS harmonization for acquisitions and strategic initiatives • Assess quality system maturity, identify compliance gaps, and implement integration plans • Support implementation and optimization of electronic Quality Management Systems and related enhancement initiatives • Support regulatory inspections, audits, and remediation activities • Lead, coach, and develop the Quality Systems team • Establish performance expectations, prioritize resources, and foster quality, accountability, and continuous improvement

🎯 Requirements

• Strong working knowledge of MasterControl, Veeva, Trackwise, or similar eQMS platforms • Solid understanding of 21 CFR 820, ISO 13485, EU MDR, and MDSAP • Demonstrated ability to manage and develop teams • Ability to balance operational priorities with compliance requirements • Strong organizational, analytical, and communication skills • Ability to collaborate across global, cross-functional groups • 8+ years of experience in quality management systems within a regulated med tech industry • 7+ years of people leadership and team development • Experience managing quality systems with ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR requirements • Bachelor's degree in Engineering, Life Sciences, Quality, or a related discipline • Standard office environment with regular use of computer systems and virtual collaboration tools • May require 20% domestic or international travel

🏖️ Benefits

• Medical coverage • 401(k) • Parental leave • Fertility benefits • Paid time off for vacation, personal, sick and holidays • Multiple other perks and benefits