Hollister Incorporated · 17 hours ago
Manager Quality Improvement & CAPA
Libertyville, IL
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expHollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The Manager is responsible for leading and improving key elements of Hollister’s Quality Management System (QMS), focusing on the CAPA process and Nonconformance programs across all locations.
Health CareManufacturing
Responsibilities
Provides leadership for establishment, improvement and maintenance of Hollister’s CAPA and Nonconformance programs
Lead, understand, champion and implement new regulations and guidelines to ensure compliance with ISO 13485 standards, 21CFRPart820 EUMDR, and other regulations as applicable
Manage and govern the CAPA process. Act as CAPA subject matter expert & coordinator for the Libertyville location
Provides guidance, direction and support across all sites and helps drive best practices
Conducts assessment of changing standards, regulations and guidance documents, and identifies any needed changes to internal policies, procedures, processes, or practice
Collaborates extensively across manufacturing sites and across functions including Quality, Regulatory Affairs, IT, Operations, R&D and other departments as applicable
Provides education on relevant quality systems and processes, and drives accountability across the organization
Analyzes process performance based on quality data & metrics and provides recommendations for improvement as applicable
Maintains up to date knowledge of all areas of responsibility which impact the Hollister Quality Management System
Qualification
Required
Number of Overall Years Necessary: 8-12
Minimum of 8 years of healthcare industry experience
Deep understanding of USA and International regulations and standards, including FDA cGMP, EUMDR and ISO 13485
Experience working in a regulated environment, quality management systems, or related field is essential, medical devices or pharma industry experience, is highly preferred
Bachelor's Degree in scientific or engineering discipline required
Advanced Degree desired
Strong problem-solving skills; ability to analyze all aspects of a situation, challenge current methods, identify potential solutions, make informed decisions and implement the best solution in an efficient, timely manner
Ability to execute on strategic initiatives and manage day-to-day deliverables
Experience with ISO13485 standard and its requirements
Experience with 21CFRpart 820, EUMDR and its requirements
Strong oral and written communication skills
Ability to build, work with, and strengthen relationships with team members in other departments, other sites, outside auditors and business partners; as well as extensive experience in leading and facilitating diverse teams, both face-to-face and in a virtual setting
Demonstrated leadership and mentor skills indicating management capabilities to meet or complete project deadlines, initiatives and schedules, as well as communicating and providing direction to team members
Demonstrated interest in, and understanding of, industry developments and trends
Ability to travel
Verbal and written communications, reading, and typing
Preferred
Experience working in a regulated environment, quality management systems, or related field is essential, medical devices or pharma industry experience, is highly preferred
Industry certifications are desirable
Problem Solving & CAPA training preferred
Certified Quality Auditor (CQA) and Certified Quality Manager (CQM) preferred
Company
Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.
1001-5000 employees
H1B Sponsorship
Hollister Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (2)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Abinash Nayak
President and COO
scott holloway
Executive Vice President and Chief Commercial Officer
Recent News
2026-01-20
Digital Music News
2026-01-06
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