Requirements: English
Company: PQE Group
Region: Novara , Piedmont
Are you ready to join a leading global consultancy in the pharmaceutical and Medical Device industry?
PQE Group has been a successful player in this field since 1998, with a global presence through 45 offices and over 2000 employees across Europe, Asia, and the Americas.
Working at PQE Group means:
- Taking part in projects with top national and international pharmaceutical companies, gaining cross-functional skills and a broad sector vision.
- Rapid professional growth supported by a multicultural team of professionals from diverse disciplines.
- Developing adaptability and project management skills to tackle the ever-changing consultancy environment.
- Opportunities to travel both nationally and internationally.
Our Medical Device & Pharma Quality team is constantly growing to meet the increasing market demand for high-quality services.
We are currently looking for a Supplier Quality Specialist to support a 6-month project in Denmark (Silkeborg) at an engineering site focused on high-precision components and delivery systems for the medical devices and pharma industry.
Key Responsibilities:
- Lead supplier qualification and re-evaluation activities for precision mechanical and plastic components used in regulated combination products.
- Conduct supplier audits (both remotely and on-site) in alignment with ISO 13485, ISO 9001, and applicable GMP principles.
- Draft and manage supplier quality-related documentation (e.g., Quality Agreements, technical questionnaires, RoHS and REACH declarations).
- Manage supplier-related deviations and non-conformities, supporting root cause analysis and verifying CAPA effectiveness.
- Maintain and update supplier records and documentation in electronic quality systems (e.g., TrackWise or equivalent).
- Collaborate with internal stakeholders (QA Operations, R&D, Procurement, and Regulatory) to align supplier capabilities with product and compliance requirements.
- Support change control processes involving suppliers or critical component changes.
About you:
- Bachelors degree in Engineering or scientific/technical discipline.
- 46 years of experience in Supplier Quality, ideally in medical device manufacturing or pharmaceutical packaging technologies.
- Solid knowledge of ISO 13485, ISO 9001, and experience in highly regulated environments (e.g., combination products, Class II/III devices).
- Familiarity with precision manufacturing processes (e.g., injection molding, machining) is considered a strong plus.
- Experience with quality systems such as TrackWise.
- Strong communication and stakeholder management skills.
- Fluent in English (spoken and written).
- Availability to work full-time on-site in Silkeborg, Denmark for the duration of the project.
Our Offer:
- Full-time employment contract.
- Competitive salary based on experience.
- Travel bonus for client-site activities.
- Coverage of accommodation, meals, and transportation expenses for the duration of the project.
- Duration: 6 months (with potential extension).
- Start: As soon as available.
Next steps:
Once your application is received, if theres a match, our HR team will contact you for an initial interview. If successful, youll move on to a technical interview with the hiring manager. Should all go well, you will receive a job offer. Otherwise, well inform you that the selection process has ended.
Working at PQE Group
Joining PQE Group means becoming part of a dynamic, multicultural company that values collaboration and innovation. Youll have the chance to work on international projects, grow your skill set, and interact with colleagues from around the world. If you''re looking for a rewarding and stimulating career, PQE Group is the place for you.
Apply now and take your first step toward an extraordinary future with us!