Devices Development Quality Lead, Randstad

Randstad

Location:

Switzerland, Bulle

Category:

Quality Control

Contract Type:

Not provided

Salary:

Not provided

Save Job

Apply Position

Job Description:

UCB, one of Switzerland's Best Employers, is an internationally active biopharmaceutical company specialising in the therapeutic areas of neurological disorders and immunology. The Bulle site is home to the company's Swiss sales subsidiary and primarily a biotechnological and chemical production platform for the manufacture and distribution of pharmaceutical specialities for the treatment of allergy, epilepsy and autoimmune diseases.

Job Responsibility:

Provide expert QA support for vendors in design, development, testing, and manufacturing of Medical Devices and Combination Products
Ensure compliance with MDR, ISO, and GMP/cGMP requirements throughout development and commercialization
Oversee Design & Development activities, including Validation/Verification, risk management, and regulatory submissions
Review and approve key documentation: design control files, Technical Documentation Files, DHF, and Verification & Validation protocols
Manage vendor quality, ensuring alignment with UCB in design, technology transfer, and quality systems
Conduct assessments/audits, negotiate Quality Agreements, and monitor vendor performance
Approve or block device release based on quality and compliance criteria
Lead investigations for deviations and change management, track CAPA events, and oversee change controls
Act as QA liaison for external vendors, supporting regulatory inspections and collaborating with Corporate QA and Technical Operations
Ensure audit readiness, maintain compliance with ISO, MDR, and GMP, and support quality system improvements
Track key performance indicators and contribute to Management Review and Design Reviews

Requirements:

Master's degree in management of Devices / Combination products or related diploma
3 to 6 years of experience in design control within the Medical Devices industry
combination products experience is a plus
Strong knowledge of ISO 13485, 21 CFR Part 820, MDR, and ISO 14971
Root cause analysis and risk management skills
Problem-solving and innovative thinking
Coaching and mentoring abilities
Strong leadership and teamwork skills
Excellent communication abilities
Fluent in English (mandatory)
French is a plus

Nice to have:

French is a plus

Additional Information:

Job Posted:

March 30, 2025

Expiration:

April 15, 2025

Employment Type:

Fulltime

Work Type:

On-site work

View All Jobs In This Company

Job Link Share: