Quality Assurance Manager

MGS Mfg. Group; Roskilde Kommune; On-site; DKK 673,000 - 897,000; Full time

Job summary

MGS Mfg. Group is seeking an experienced Quality Manager for the EU Tooling Group, spanning Roskilde, Denmark and Anderstorp, Sweden. You will lead the QMS development, digitalization and cross-site alignment with management and process owners.

Strong knowledge of ISO 9001/ISO 14001 and audits is essential; experience with MasterControl and global quality projects is an advantage. Fluent English and Danish/Swedish communication preferred.

Qualifications

• Proven experience within quality management and development of Quality Management Systems.
• Strong knowledge of ISO 9001 and ISO 14001.
• Experience with internal and external audits.
• Experience with digital Quality Management Systems.
• Experience with MasterControl or a similar digital QMS platform is an advantage.
• Experience with controlled documentation, SOPs, non-conformities, root cause analysis and corrective actions.
• Ability to translate standards and compliance requirements into simple, effective and practical processes.
• Experience working with process owners and cross-functional teams.
• Strong communication skills, both verbal and written.
• Fluent in English and able to communicate in either Danish or Swedish.
• Education or certification as an Internal Auditor or Lead Auditor is considered an advantage.

Responsibilities

• Overall responsibility for the EU Tooling Group Quality Management System.
• Maintain and improve the QMS in accordance with ISO 9001 and ISO 14001.
• Establish and maintain a common QMS across Roskilde and Anderstorp.
• Drive the digitalization and implementation of the QMS.
• Act as advisor and sparring partner for management and process owners.
• Support process owners in developing, documenting, implementing and improving their processes.
• Ensure effective document control of policies, procedures, SOPs, and other controlled documentation.
• Ensure QMS training and awareness across the organization.
• Plan, conduct and follow up on internal audits.
• Coordinate and lead external audits and certification activities.
• Manage and follow up on non-conformities, root cause analyses and corrective actions.
• Monitor QMS performance, risks and improvement opportunities.
• Report quality performance, risks and improvement initiatives to management.
• Plan and facilitate Management Review meetings and ensure follow-up on agreed actions.
• Support a strong culture of quality, compliance and continuous improvement across EU Tooling.

Skills

Quality management

ISO 9001

ISO 14001

Audits

Digital QMS

MasterControl

Documentation & SOPs

Root cause analysis

Cross-functional collaboration

Fluent English

Tools

MasterControl

Job description

At MGS, we are among the few in the world specializing in high-end injection molding tools for the medical industry. We are an international company with a strong local presence and proud pioneers in our field. We invest purposefully in both technology and employees to ensure that we are always at the forefront of innovation and performance.

We are looking for an experienced Quality Manager for our EU Tooling Group, covering our two sites in Roskilde, Denmark, and Anderstorp, Sweden.

You will hold the overall responsibility for developing and maintaining our Quality Management System and for ensuring that both sites work according to one common, effective and practical QMS.

A key part of the role will be to further develop and digitalize our QMS and create a strong common quality framework across EU Tooling. You will work closely with management, process owners and employees to ensure that quality requirements are translated into processes that work in practice.

Key Responsibilities

• Overall responsibility for the EU Tooling Group Quality Management System.
• Maintain and continuously improve the QMS in accordance with ISO 9001 and ISO 14001.
• Establish and maintain one common and consistent QMS across Roskilde and Anderstorp.
• Drive the digitalization and implementation of the QMS.
• Act as advisor and sparring partner for management and process owners.
• Support process owners in developing, documenting, implementing and improving their processes.
• Ensure effective document control of policies, procedures, SOPs, work instructions and other controlled documentation.
• Ensure relevant QMS training and awareness across the organization.
• Plan, conduct and follow up on internal audits.
• Coordinate and lead external audits and certification activities.
• Manage and follow up on non-conformities, root cause analyses and corrective actions.
• Monitor QMS performance, risks and improvement opportunities.
• Report quality performance, risks and improvement initiatives to management.
• Plan and facilitate Management Review meetings and ensure follow‑up on agreed actions.
• Support a strong culture of quality, compliance and continuous improvement across EU Tooling.

Qualifications

• Proven experience within quality management and development of Quality Management Systems, preferably from a technical or manufacturing environment.
• Strong knowledge of ISO 9001 and ISO 14001.
• Experience with internal and external audits.
• Experience with digital Quality Management Systems.
• Experience with MasterControl or a similar digital QMS platform is an advantage.
• Experience with controlled documentation, SOPs, non-conformities, root cause analysis and corrective actions.
• Ability to translate standards and compliance requirements into simple, effective and practical processes.
• Experience working with process owners and cross-functional teams.
• Strong communication skills, both verbal and written.
• Fluent in English and able to communicate in either Danish or Swedish.
• Education or certification as an Internal Auditor or Lead Auditor is considered an advantage.

Personal Qualities

• Structured and analytical with a strong sense of the bigger picture.
• Proactive and able to drive improvements from idea to implementation.
• Strong stakeholder and relationship management skills.
• Pragmatic and solution-oriented, with the ability to make quality requirements practical and understandable.
• Comfortable working independently while collaborating across functions, sites and organizational levels.
• Results‑driven and committed to ensuring that processes are not only documented but also understood and used in practice.

We Offer

An exciting and versatile role in an international company with high professionalism, great influence and short decision‑making paths.

You will have a central role in shaping the future quality set‑up for EU Tooling and the opportunity to:

• Build one common Quality Management System across two sites.
• Drive the continued digitalization of our quality processes.
• Work closely with management and process owners across the organization.
• Influence how we work with quality, environment and continuous improvement.
• Collaborate across Denmark, Sweden and the wider global MGS organization.
• Become part of an international organization with strong focus on quality, technology and development.
• Flexible working hours and salary according to qualifications.

Interested?

If you want to know more, you are welcome to contact Stine Pedersen, HR Manager EU Tooling, at [e-mail].

We conduct interviews on an ongoing basis and encourage you to send your application as soon as possible.

We look forward to hearing from you.

About MGS

MGS is a global provider of manufacturing solutions for the healthcare industry. We combine strong technical expertise and agile collaboration methods – and are therefore the preferred partner for leading players in Pharma, Diagnostics, and MedTech.

We serve customers from strategically located facilities worldwide and turn their biggest challenges into solutions that improve lives.

Learn more at mgsmfg.com.