Sr. QA Engineer

Hollister Incorporated; Roosendaal; Hybrid; EUR 52,000 - 74,000; Full time

Job summary

Hollister Incorporated in Roosendaal, Netherlands, seeks a Senior Quality Assurance Specialist to strengthen the site QMS and ensure regulatory, quality, and product compliance. You will lead or support audits, CAPA, change controls, risk assessments, and cross-functional improvements, collaborating with Operations and Global Quality to drive inspection readiness.

This role requires 5-8 years in quality within GMP/medical device settings, strong communication in English and Dutch, and a

Qualifications

• Five to eight years of overall experience in quality roles.
• Experience in GMP/GDP regulated pharma/medical device environments.
• Proven track record supporting QMS processes, audits, CAPA, and change control.
• Ability to prepare clear technical reports, risk assessments, and documentation.
• Strong communication and stakeholder management skills.
• English and Dutch language proficiency required.

Responsibilities

• Apply advanced knowledge of medical device quality systems and regulatory requirements to support site operations.
• Lead or support site QMS processes, workflows, documentation controls, and training.
• Prepare for and support internal, external, and regulatory audits with follow-up evidence.
• Provide input on material disposition, process controls, CAPA, change control, and related decisions.
• Present quality, risk, and compliance information clearly to stakeholders and regulators.
• Use structured problem-solving (Fishbone, DMAIC, 5-Whys) to identify root causes and implement controls.
• Lead or participate in cross-functional, global project teams to drive quality deliverables.
• Facilitate FMEA, risk assessments, validation planning, and risk-based validation strategies.
• Coach and mentor colleagues in quality processes, audit readiness, and documentation.

Skills

Quality Assurance

Regulatory Compliance

QMS

Audits

CAPA & Change Control

Risk Assessment

DMAIC / 5-Whys

Cross-functional Collaboration

Education

Bachelor's degree in quality, engineering, life sciences, or related field

Job description

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We Make Life More Rewarding and Dignified

Summary:

The Senior Quality Assurance Specialist supports and strengthens the facility Quality Management System (QMS) to help meet applicable regulatory, compliance, and product quality requirements. The role leads or contributes to quality projects, process analysis, audits, investigations, risk assessments, validation activities, and cross-functional improvement initiatives. It partners with Operations and Global Quality stakeholders to ensure procedures, records, training, and quality decisions are clear, compliant, and aligned with organizational quality objectives.

Hollister operates in a hybrid work environment. Associates are expected to come to Roosendaal facility a minimum of 4 days per week.

Responsibilities:

• Apply advanced knowledge of medical device quality systems, external regulatory requirements, and quality assurance practices to support compliant facility operations.
• Lead or support site-specific QMS processes, work instructions, quality records, documentation controls, and training related to assigned areas of expertise.
• Prepare for, execute, and support internal, external, and regulatory audits, including follow-up actions and evidence of compliance.
• Provide sound quality input on material disposition, process controls, change controls, CAPA activities, and related compliance or product quality decisions.
• Present complex quality, risk, and compliance information in a clear, concise, and well-documented manner suitable for review by internal stakeholders or regulatory bodies.
• Use structured problem-solving approaches such as Fishbone analysis, DMAIC, 5-Whys, or similar tools to identify root causes and implement effective corrective and preventive controls.
• Lead or participate in cross-functional and global project teams using project management fundamentals to drive quality-related deliverables.
• Facilitate or support process FMEA, risk assessments, validation planning, and risk-based validation strategies.
• Coach, train, and mentor colleagues in relevant quality processes, documentation expectations, audit readiness, and technical quality practices.
• Perform other quality-related duties as assigned, consistent with the scope and seniority of the role.

Essentials of the Role:

• Maintain and improve assigned QMS processes, procedures, records, and supporting documentation in accordance with applicable quality and regulatory requirements.
• Execute or support audits, investigations, CAPA actions, change controls, risk assessments, validation activities, and other quality system deliverables.
• Review, analyze, and document quality information with accuracy, attention to detail, and appropriate technical judgment.
• Communicate quality expectations, risks, findings, and decisions clearly to cross-functional stakeholders, including Operations and Global Quality partners.
• Support audit readiness by ensuring documentation, evidence, and process knowledge are current, understandable, and inspection-ready.
• Collaborate effectively in team settings and contribute to a culture of compliance, continuous improvement, and product quality.
• Use relevant digital tools and systems to document, track, report, and communicate quality activities.
• Working knowledge of ISO 13485, GMP, GDP, and other applicable quality/regulatory frameworks

Must have Requirements:

• Number of Overall Years Necessary: 5-8
• Minimum of 2-5 years in Quality position required within experience in the Good Manufacturing Practice Regulated Pharma/Medical Device industry. Additionally experience in a Distribution Quality Role would be advantageous as would expertise in TWI training methodology
• Bachelor’s degree or equivalent education/experience in a relevant technical discipline such as quality, engineering, life sciences, medical device, pharmaceutical, food science, or a related field.
• Relevant quality assurance experience in a regulated environment, preferably within medical device, pharmaceutical, GMP/GDP, distribution quality, or a comparable technical setting.
• Demonstrated experience supporting QMS processes, audits, documentation, investigations, CAPA, change control, risk assessment, or validation activities.
• Ability to write clear technical reports, procedures, risk assessments, and quality documentation that can withstand internal and external review.
• Strong communication, collaboration, prioritization, and stakeholder management skills.
• Proficiency with standard computer applications and quality-related systems used to manage records, documentation, investigations, and project activities.
• Ability to communicate both verbally and in written form in English & Dutch.

Preferred Requirements:

• Auditor training or demonstrated experience preparing for, conducting, or hosting internal, external, or regulatory audits.
• Experience in distribution quality or regulated distribution center operations.
• Experience with Training Within Industry (TWI) or a comparable training methodology.
• Experience applying structured problem-solving, process FMEA, risk-based validation, and project management practices.
• Ability to coach, teach, or mentor others in quality system processes, technical documentation, or audit readiness.

The salary range for this position is 52,000 - 74,000 EUR annually.

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services and its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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