Conduct internal audits: Evaluate the effectiveness of our QMS processes, documentation, and records. Identify areas that deviate from standards, opportunities for improvement, effective approaches, and possible risks. Verify compliance with all applicable regulations and standards. Stay updated on ISO 13485:2016 standards and related regulatory changes. Assist in the development and maintenance of QMS documentation, including policies, procedures, and work instructions. Collaborate with cross-... more details
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Location/Division Specific Information
Middletown, VA
Specialty Diagnostics Group (SDG)
How will you make an impact?
We are excited to offer an excellent opportunity for an Internal Auditor at Thermo Fisher Scientific Inc., a leading manufacturing company. In this role, you will be responsible for ensuring compliance with ISO 13485:2016 requirements, improving our Quality Management System (QMS), and driving ongoing enhancements. Your strong auditing skills and expertise in ISO 13485:2016 standards will be essential in identifying areas for improvement and implementing effective corrective actions to elevate our quality processes.
Responsibilities:
- Conduct internal audits: Evaluate the effectiveness of our QMS processes, documentation, and records. Identify areas that deviate from standards, opportunities for improvement, effective approaches, and possible risks. Verify compliance with all applicable regulations and standards.
- Stay updated on ISO 13485:2016 standards and related regulatory changes. Assist in the development and maintenance of QMS documentation, including policies, procedures, and work instructions. Collaborate with cross-functional teams to address compliance gaps and implement corrective actions.
- Corrective and preventive actions: Monitor and track the progress of corrective actions to ensure timely completion. Conduct follow-up audits to verify the effectiveness of implemented actions.
- Reporting and communication: Prepare comprehensive audit reports detailing findings, recommendations, and corrective actions. Present audit results to management and other relevant parties, highlighting areas of concern and proposing solutions. Communicate effectively with internal teams to provide guidance on QMS requirements and facilitate knowledge sharing.
- Continuous improvement: Discover ways to improve process efficiency and operational effectiveness in the QMS. Participate in quality-related projects and initiatives to drive continuous improvement. Keep up-to-date with the latest industry guidelines and emerging trends in QMS and regulatory compliance.
Education:
- Bachelor's degree in a relevant field such as Biological Sciences or Engineering
Experience:
- Five (5) years of experience
- Professional certification such as ASQ Certified Quality Auditor (CQA), or equivalent experience in quality auditing.
- Extensive knowledge of ISO 13485:2016 standards and related regulatory requirements.
- Proven experience in conducting internal audits and implementing QMS improvements.
Skills:
- Strong analytical skills and attention to detail.
- Strong communication and interpersonal skills to effectively work with individuals at all levels.
- Ability to work independently and manage multiple projects simultaneously.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
