Are you dedicated to upholding the highest standards of quality within medical device sector? Do you excel in dynamic environments, ready to leverage your expertise for meaningful impact? If so, consider joining a pioneering company focused on healthcare innovation.

About Us:

Our client is a prominent player in the healthcare industry, committed to delivering inventive solutions that elevate global patient care standards. Our mission is to transform the medical landscape by ensuring unwavering quality in our products and services. Operating at the intersection of technology, healthcare, and quality assurance, we push boundaries and establish new benchmarks.

Job Overview:

As the Quality Manager with us, you will lead the charge in maintaining the highest standards of quality across both our internal processes and external collaborations. Your role is pivotal in selecting, nurturing, and overseeing contract manufacturers, collaborating closely with cross-functional teams to fortify our Quality Management System. Your mission is to champion consistent product quality, propel continuous improvement, and contribute to effective life-cycle management.

Key Responsibilities:

• Spearhead the development and execution of our Quality Management System.
• Supervise internal and external quality processes, ensuring alignment with ISO 13485 and GMP standards.
• Offer expert guidance in selecting, developing, and overseeing contract manufacturers.
• Collaborate with cross-functional teams to drive continuous improvement initiatives.
• Conduct quality audits and assessments to pinpoint areas for enhancement and guarantee compliance with regulatory requirements.
• Act as a key influencer, cultivating a quality-focused culture throughout the organization.
• Establish effective communication channels for quality-related matters, both internally and externally.

Qualifications:

• 5+ years of experience in pharmaceutical/medical device quality and auditing roles.
• Experience in the life science industry and in GMP, preferably in medical device projects
• Knowledge on quality system standards (ISO 13485), regulatory standards for Medical Devices (21CFR820 & EU MDD/MDR) or software used for Medical Devices (IEC 62304) is a big plus
• First experience with audits is an advantage
• Good project management skills
• Exceptional communication skills with the ability to influence personnel at all organizational levels.
• Proficiency in written and spoken English.

If you are interested in finding out more about this opportunity, click apply and/or give me a call!

James Prentice

Executive Recruitment Consultant

james.prentice@darwinrecruitment.com

+41 41 506 29 25

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

James Prentice