Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
Review our company's Total Rewards
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement - eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Now is an exciting time to join our Nashville Manufacturing & Distribution team, a team dedicated to ensuring our customers receive the products they need to achieve their scientific goals - quickly, reliably, and safely. If you believe in working the right way for the right reason join our growing team today!
How will you make an impact?
As a Senior member of the Quality Assurance Team, the Quality Engineer III will ensure compliance with industry standards and be a key contributor to meet quality objectives for the Single Use Technologies business (bio-processing containers). These best in class systems are used to develop and commercially manufacture biopharmaceutical medicines that are used to treat diseases and improve the quality of life of patients.
What will you do?
The QA Engineer III is responsible for maintaining and improving the Quality System for the Plant. This role will ensure that quality objectives are met for the plant and assuring compliance with industry standards. This role will also determine, organize, and apply necessary resources to meet identified Quality Requirements. This individual will perform customer complaint investigation, perform assessments of Non-conforming material and deviations, lead CAPA investigation and support site quality performance metrics. Additionally, this role may support process validation activities.
The role demands a solid background working in a regulated manufacturing environment with Quality Systems experience (i.e. ISO 13485:2016, 21 CFR 820).
Responsibilities Include:
- Participate & Maintain Investigative Processes (PNs, Deviations, CAPA)
- Participate in self inspection (internal audits) activities as assigned
- Maintain Information relating to COPQ (Cost of Poor Quality) from Non-Conformance Reports (NCMS)
- Review and approve documents (SOPs, WIDs, PCDs, FCDs)
- Evaluation and review of Qualifications & Validations
- Review and approve specifications (SPECS)
- Support customer audits
- Complete trending and evaluation of PNs, Deviations, CAPA for review during Quality Road Map & Annual Management Review meetings
- Facilitate quality department process improvements and projects
- Super user of Quality System Software (i.e. MasterControl, Trackwise)
- Support the validation function by assisting with validation documentation, performing qualification protocols and compiling data
- Lead CAPA investigations
- Lead multi-functional team members supporting the Customer Complaint Process
- Complete Risk and Impact Assessments
- Interact directly with customers and internal groups
- Drive product and process changes to improve product quality
- Other tasks as assigned
- Bachelor's degree in Engineering field or 5 years direct Quality Engineering experience; OR Master's degree in Engineering field with 3 years of relevant experience.
- Minimum 4 years of working with Quality Management Systems
- 5 years of hands-on experience leading investigation processes includes CAPA, NCM, complaint and/or root cause investigations.
- Experience working in a regulated environment (e.g. ISO 13485:2016, 21 CFR 820, MDSAP)
- Good understanding of cGMP, GDP, and ISO 13485:2016 and 21 CFR 820) requirements
- Innovative thinking and problem-solving skills (root cause analysis, CAPA)
- Attention to detail and ability to identify and remediate compliance issues
- Highly effective verbal and written skills
- Self-motivated, proactive, and capable of adhering to deadlines
- Ability to work well under pressure and multi-task
- Proven knowledge of Quality Management System tools
- Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
- Excellent interpersonal, organizational, and influencing skills
- Proficient with Microsoft tools; Word, Excel, Power Point, Visio, Teams
- ASQ certification is desired
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.
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