Quality Engineer III
Quality Engineer III
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Job Description
Work Schedule
First Shift (Days)Environmental Conditions
Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed OfficeJob Description
Location/Division Specific Information
Now is an excellent time to join our Nashville Manufacturing & Distribution team a team committed to ensuring our customers receive the products they need to achieve their scientific goals quickly reliably and safely.
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 have a key role in meeting quality objectives for the Single Use Technologies business (bio-processing containers). These outstanding 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 instrumental to maintaining and improving the Quality System for the site. 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.
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Responsibilities Include:
- Participate & Maintain Investigative Processes (Complaints Deviations CAPAs)
- Participate in internal and customer audit activities as assigned
- Complete trending and evaluation of Complaints Deviations CAPAs for actions and Management Review meetings
- Facilitate quality department process improvements projects
- Support the validation function by assisting with validation documentation performing qualification protocols and compiling data
- Lead multi-functional team in CAPA and complaint investigations
- Complete Risk and Impact Assessments
- Directly work with customers and internal groups
How will you get here
- Minimum Required Education: Bachelors degree in Engineering or related field
- 5 years direct Quality Engineering experience
- Minimum 4 years of experience 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)
Knowledge Skills Abilities
- 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 timelines
- 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
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an engaging company culture that stands for integrity intensity involvement and innovation.
Employment Type
Full-Time
