Posted 2mo ago

Quality Specialist QMS & Audits

@ Oliver Healthcare Packaging
Venray, Netherlands, Netherlands
OnsiteFull Time
Responsibilities:maintain QMS, lead audits, improve quality
Requirements Summary:Bachelor's degree or equivalent; 3+ years in a quality role within a regulated environment; QMS/audit experience; ISO 13485; GMP/EU MDR knowledge; proficient in MS Office, SAP, document control.
Technical Tools Mentioned:MS Office, SAP, Document Control System, QMS software
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Job Description

Quality Specialist QMS & Audits


We are searching for an experienced Quality Specialist QMS & Audits at our Venray facility. 

Primary Duties and Responsibilities: 

As a Quality Specialist QMS & Audits (1 FTE), you
are responsible for safeguarding and continuously improving quality systems,
audit processes, and quality administration within a highly regulated
environment. You manage and maintain the Quality Management System (QMS) in
line with internal procedures, regulatory requirements, and applicable
standards. This includes ensuring accurate and up-to-date documentation and
supporting departments in creating, revising, and approving procedures within
the document control system.

You act as the primary point of contact for customer and
external audits. You prepare and lead internal and external audits, coordinate
audit follow-up activities, and maintain the audit schedule. You collaborate
closely with customers, notified bodies, and internal stakeholders to ensure
that non-conformities and complaints are addressed in a timely and sustainable
manner.

In addition, you actively contribute to quality improvement
initiatives. You analyze data from risk analyses, CAPAs, complaints, and QMS
trends and translate insights into concrete improvement actions. You perform
root cause analyses, implement sustainable solutions, and support or lead
cross-functional improvement projects focused on product quality, customer
satisfaction, and audit readiness.

You also monitor developments in legislation and
regulations, such as EU MDR, as well as evolving customer requirements. You
ensure these are effectively translated into the QMS and the organization,
contributing to a strong quality culture and continuous improvement through
your analytical and structured approach.

At Oliver, we value your personal values just as much as
your expertise. We believe you truly belong when work feels like more than just a
job, and we invest a lot to make that happen.

 

What makes working at Oliver so great?

  •  Innovation everywhere:
    Work with a state-of-the-art machine park in one of Oliver’s largest cleanrooms
    worldwide. Continuous development drives continuous change.
  • A close-knit team:
    We are more than colleagues. We care about each other’s well-being, know each
    other by name, and work together towards shared success.
  • Your expertise matters:
    At Oliver, you have the freedom to apply and grow your technical expertise
    every day. Your contributions are truly valued.
  • International opportunities, local convenience:
    Enjoy an international working environment—right close to home.
  • Work–life balance:
    Benefit from 27 vacation days and an attractive bonus scheme.
  • Focus on vitality:
    Daily fresh fruit, a bike or fitness plan, and generous healthcare
    reimbursements through the ASF fund.
  • Celebrating together:
    Join our annual employee events and celebrate success, collaboration, and fun

Ready to share your story?
We are excited to hear your story and learn about the next
steps you want to take in your career. Apply directly, or let us contact
you for an informal conversation.



Required Qualifications:

What do we ask from you for this role?

  •  Education and experience:
    You hold a bachelor’s degree or equivalent level of thinking
    and working, with at least three years of experience in a quality-related role
    within a regulated environment.
  • Knowledge and expertise:
    You have experience with QMS management, auditing, and ISO
    13485. Knowledge of GMP, EU MDR, cleanrooms, and continuous improvement
    methodologies is a plus.
  • Systems and skills:
    You work in a structured and analytical manner, prepare
    procedures and reports with care, and are proficient in MS Office, SAP, and
    document control systems.
  • Communication skills:
    You communicate professionally and clearly in English, both
    verbally and in writing, and interact easily with customers, auditors, and
    internal stakeholders.
  • Collaboration and mindset:
    You are a proactive team player with a strong focus on
    quality, collaboration, and continuous improvement.
    At Oliver, it’s about more than just qualifications—we place
    great value on our culture. Do our core values resonate with you?




Salaried

Annually

0.00 - 0.00

Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.