By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
The Senior QA/RA Engineer supports the Head of Quality Assurance and Regulatory Affairs (QA/RA) in overseeing and maintaining the Quality Management System (QMS) and ensuring that all Lunaphore products comply with applicable regulatory requirements.
Job Responsibilities:
1. Assist the Head of QA/RA in managing team resources by allocating personnel to projects according to organizational priorities.
2. Lead and oversee QA/RA-related projects assigned to the Senior QA/RA Engineer.
3. Implement, maintain, and continuously improve the company's Quality Management System in accordance with ISO 9001 and ISO 13485 standards.
4. Ensure product compliance with relevant quality and regulatory requirements throughout the entire lifecycle—from development through post-market activities.
5. Monitor and adhere to QA/RA deadlines while maintaining accurate and up-to-date documentation.
6. Participate in and lead internal and external audits.
7. Collaborate closely with the R&D team to ensure product development aligns with regulatory and quality requirements.
8. Provide regular updates and reports to the Head of QA/RA.
9. Support the Head of QA/RA in liaising with external parties, including notified bodies, competent authorities, and regulatory consultants.
Qualifications:
1. Degree in Engineering with certification in Quality Assurance and/or Regulatory Affairs preferred.
2. Minimum of 5-8 years’ experience in implementing and/or maintaining a QMS.
3. Certified Lead Auditor for ISO 9001 or ISO 13485.
4. Strong understanding of quality standards applicable to the in vitro diagnostics (IVD) industry.
5. Solid knowledge of the IVD regulatory landscape (EU, USA).
6. Excellent written and spoken English; proficiency in French is a strong asset.
Personal skills:
1. Adaptability in a dynamic and evolving work environment.
2. Strong interpersonal skills and a collaborative mindset suited to a multidisciplinary setting.
3. Exceptional organizational skills, attention to detail, and the ability to manage multiple priorities and meet deadlines with minimal supervision.
Why Join Bio-Techne:
1. We offer competitive wages along with extensive benefits for employees and their families.
2. We invest in our employees’ financial futures through retirement programs and an employee stock purchase plan.
3. We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
4. We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging.
5. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
About Us
Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services.
Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.
#J-18808-Ljbffr