Senior Quality Partner - QMS Medical Devices
Senior Quality Partner - QMS Medical Devices
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
We are seeking a knowledgeable and experienced ISO 13485 Quality Management Expert to lead and support the implementation and maintenance of our Quality Management System (QMS) in compliance with ISO 13485:2016 MDSAP and relevant regulatory requirements. The ideal candidate will play a key role in ensuring that our medical device products meet the highest standards of quality and safety.
Lead the development implementation and continuous improvement of the QMS in accordance with ISO 13485 and applicable regulatory requirements (e.g. FDA 21 CFR Part 820 MDR).
Prepare for and manage internal and external audits (including notified body regulatory agency).
Conduct risk assessments gap analyses and process validations.
Ensure proper documentation training and compliance across all quality-related functions.
Support the creation and revision of SOPs work instructions forms and other quality documents.
Collaborate with cross-functional teams (engineering regulatory affairs Global Q&R etc.) to ensure product and process quality throughout the lifecycle.
Monitor quality KPIs and prepare reports for management review
Identify and lead corrective and preventive actions (CAPAs) non-conformances (NCs) and root cause analyses (RCAs).
Provide ISO 13485 and QMS training to employees at all levels.
Monitor training compliance for the site
5 Years experience; recognised internally as an expert in own job discipline.
Bachelors / Master degree in Life Science Data Science Engineering or related subject or equivalent experience. Experience working in a Software as a Medical Device (SaMD) environment is preferred.
In-depth knowledge of ISO 13485 ISO 14971 IEC 62304 IEC 82304 FDA QSR EU-MDR and legislation for Software as a Medical Device or IVD.
Knowledge of ISO 27001 family of standards HITRUST HIPAA and GDPR will be an advantage.
Experience in preparing for and participating in audits and inspections.
Strong analytical problem-solving and communication skills.
Certification in ISO 13485 auditing (e.g. Lead Auditor) is preferred.
Familiarity with electronic QMS systems and tools is a plus.
Has worked in more than one function within quality management and may have worked outside of Quality Management. Can manage highly complex and/or global projects or equivalent experience.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Senior IC
Employment Type
Full-Time
