Are you looking for a new challenge as Manager Quality Assurance? 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 read on quickly...
Key accountabilities:
- 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, know-how 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
- Abilit y 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 people management skills
- 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 and 13 adv-days for a 40-hour full-time job
- 8% holiday pay
- 13th month
- Bonus scheme
- 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. Your own laptop and smartphone. 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 QA Manager Operations?
Are you up for this? Then apply directly via the red button! Do you still have questions? Then contact Monique Meiling our Global Recruiter: m.meiling@dorcglobal.com.