Manager QA Operations

DORC Dutch Ophthalmic Research Center (International)

Zuidland

On-site

EUR 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

27 holidays for a 40-hour full-time job

8% holiday pay

13th month

Travel allowance of € 0.23/km

Non-contributory pension

Job summary

A leading medical technology firm in Zuidland, Netherlands is seeking a Manager QA Operations to ensure compliance with quality standards and lead a quality team. This mid-senior level role involves developing quality strategies, conducting audits, and overseeing product specifications. The ideal candidate has extensive experience in quality assurance within a regulated environment and is proficient in both Dutch and English. Competitive compensation and benefits including 27 holidays, 8% holiday pay, and a travel allowance are offered.

Qualifications

Minimum 5 years in a senior role in Quality Assurance in a regulated environment.
Solid understanding of quality system requirements set by major regulatory frameworks.
Ability to effectively translate quality requirements into practical directions.

Responsibilities

Contribute to the development and execution of the Quality Strategy.
Ensure that products released meet regulatory approved specifications.
Verify compliance with regulations through internal audit program.
Lead CAPA and field safety actions; drive non-conformity resolutions.
Educate and advise organization on quality/compliance matters.
Act as Deputy Management Representative and lead QA team development.
Escalate and resolve quality or compliance concerns promptly.
Collaborate on strategic company projects.

Skills

Quality Assurance

Leadership

Regulatory Compliance

Project Management

Fluent in Dutch and English

Microsoft Office Suite

Education

Bachelor's degree in Engineering

Qualification in Quality Assurance (e.g. six-sigma, lean)

Tools

Microsoft Office

Job description

5 days ago Be among the first 25 applicants

Direct message the job poster from DORC Dutch Ophthalmic Research Center (International)

Are you looking for a new challenge as Manager QA Operations and are you great at, together with your team, keeping the quality management system up to date so that it complies with the QMS standards and regulations of the countries where DORC is marketed? And do you lead the team on the continuous improvement of the by QMS controlled processes aimed at increasing efficiency and effectiveness and ensure continuing compliance? And are you a real people manager? Then please read on quickly...

Tasks and responsibilities:

Contribute to the development and execution of the DORC Quality Strategy
Ensure that DORC products that are released to distribution meet the regulatory approved product specifications (PRRC for product release and sterilization)
Verify the level of compliance with regulations and procedures by owning and driving the internal audit program
Report on the effectiveness and level of compliance of the QMS through management review and other management oversight meetings based on measurement and analysis of relevant KPIs
Prepare for and host external audits and drive resolution of associate non-conformities
Educate, train and advise the organization on quality and compliance matters
Own and drive the corrective and preventive action process (CAPA), including field safety corrective actions as necessary
Ensure that protocols, reports and records created as part of product and process development as well as changes in products and processes are critically independently reviewed for content and compliance.
Participate in strategic projects of the company
Timely escalation and resolution of quality or compliance concerns
Act as Deputy Management Representative
Lead, direct and develop the quality team members

Skills, education and experience:

Minimum 5 years in a senior role in Quality Assurance in a regulated environment, preferably medical devices
Solid understanding of quality system requirements set by the major regulatory frameworks
Relevant experience in managing and overseeing quality aspects in product development and production, preferable in disposable and active products
Ability to effectively translate quality requirements into practical directions for the organization
High level of integrity and ethical standards
Ability to multi-task and methodically manage projects based on business priorities and resource availability
Ability to self-motivate, and work independently in a geographically separated multi-national and multi-functional team environment
Collaborates effectively across a diverse network of strong personalities.
Open minded for improvement opportunities and change towards striving for best-in-class compliance performance.
Ability to think creatively, proactively identifying alternative solutions to problems
Good communication/interpersonal skills
Fluent in Dutch and English (written and spoken)
Advanced level in Microsoft Office suite applications.
Minimum Bachelor degree in a relevant field of engineering
Qualification in Quality Assurance (e.g. six-sigma, lean)

Does DORC make you happy?

Does working for you mean working together? Realising surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organisation where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC is the place for you.

Would you like to know more about working at DORC? Then read on here.

What does DORC have to offer you?

At DORC, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:

27 holidays for a 40-hour full-time job
8% holiday pay
13th month
A travel allowance of € 0.23/km
And a non-contributory pension, which means you will receive a substantially higher net salary

What else can you expect from us? Every opportunity to learn and grow. And a fantastic company restaurant full of delicious, fresh products.

Did you know ...?

DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.

DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.

Will you be our new Manager QA Operations?

Are you up for this? Then apply directly via the red button! Do you still have questions? Then contact Anne Prins-Hooijmans, our Global Recruiter: a.prinshooijmans@dorcglobal.com.

An assessment or the request for a Certificate of Good Conduct (VOG) may be part of the selection process.

Seniority level