This position will be responsible for supporting the Regulatory Affairs and Quality Assurance initiatives at Leica Biosystems (LBS) Buffalo Grove. The position will provide Regulatory and Quality support in the maintenance and improvement of facility/corporate wide quality management systems and support processes to ensure compliance with applicable regulations and standards. The RA/QA Systems Specialist is experienced in multiple areas of medical device Regulatory Affairs and Quality Assurance and is capable of applying that experience and knowledge across Leica and Danaher as a representative on improvement initiatives.
Support quality system to ensure compliance to all applicable requirements and standards (FDA Part 820, 803, 806, Part 11, Health Canada and ISO 13485) and implement process improvements to ensure continued compliance and sustained improvements
Supports Quality System element compliance (i.e. Document Control, Training, Complaints, Management Reviews, Internal Audits, etc.) for RA/QA and other departments including Sales, Marketing, Customer Support, etc.
Assist with Recall activities, MDR investigations, manage CAPA's and complete site Internal audits
Assist with implementation of electronic Quality Management Systems and serves as site's technical Subject Matter expert for those systems
Participate in development of training materials and conduct training sessions for personnel on applicable site Regulatory and Quality regulations/requirements along with product specific Regulatory training (i.e. complaint handling and adverse event escalation, classification of products, product claims)
Presents quality performance metric data to QA/RA Management and other technical cross-functional area owners to improve the Quality Management System and drive increased system compliance
Provide technical, regulatory and quality support to Customers, Leica personnel and other OpCo's
Support other sites in their maintenance and improvement of local Quality systems; design, engineering, manufacturing and operations activities to improve performance in design and manufacturing quality assurance
Training and Experience
Bachelor's Degree in scientific or medical field (i.e biology, regulatory or quality)
Minimum 3-5 years of experience in a technical or quality role preferably in a medical device ISO 13485 certified facility.
Certified Quality Auditor (CQA) Certification, ISO13485 Lead Auditor or equivalent experience preferred.
Knowledge, Abilities and Skills
Proficiency in MS Office, including Excel, Word, and Powerpoint.
Strong communication skills, both orally and written, at all levels of an organization.
Strong understanding of cGMP, ISO 13485, ISO 9001 and FDA Quality Systems; work experience in an FDA regulated company preferred.
Specific experience in driving compliance of quality systems.
Experience with problem solving and continuous improvement tools is required.
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page
Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.