Supplier Quality Engineer at Thermo Fisher Scientific in Lenexa, Kansas
Posted in Other about 14 hours ago.
Job Description:
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
Location/Division Specific Information
Reports To: Supplier Quality Supervisor
Location: UK (Basingstoke) & US (Lenexa)
Discover Impactful Work:
Working with the Quality Team, the Supplier Quality Engineer (SQE) will have extensive supplier development experience within a high paced manufacturing or similar and relevant environment.
The Supplier Quality Engineer (SQE) in the Microbiology Division will be responsible for improving Supplier and 3rd party manufacturer Quality performance and ensuring consistency to Quality Management System requirements whilst driving root cause analysis and the ongoing development of increased supplier capability. This role will support the management of supplier relationships from a quality perspective, ensuring that all quality issues are resolved in a timely fashion.
The SQE will work closely with suppliers, internal cross-functional teams, and regulatory bodies to ensure compliance with relevant regulations and standards, including ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other applicable quality system requirements.
A day in the Life:
- Ensure accurate supplier data and approved supplier list is maintained in conjunction with the Purchasing department.
- Supporting cost saving activities and process control requirements within the supply chain and collaborate with suppliers on process improvement and value enhancement opportunities.
- Lead and undertake supplier audits / assessments and report on Key Performance Indicators through objective assessments of supply chain performance and product quality.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) for supplier-related quality issues.
- Participate in internal and external audits, providing support to MBD sites and documentation as needed.
- Participate in cross-functional teams to support new product introductions and changes to existing products.
- Assist in the supplier approval process by assessing manufacturing/technology capabilities.
- Work with inhouse Engineering, R&D and Manufacturing departments to define process parameters ensuring that supplier process capability is effective to meet design intent.
- Any other tasks/duties deemed to be within the competence of the post-holder.
Keys to Success:
Education
- Bachelor's degree in science subject area or related field .
Experience
- Work experience as a Supplier Quality Engineer or relevant role in quality in Medical Device, Pharma or Automotive supply chain management
- Solid understanding of GMP, EU Regulation or ISO13485:2016.
Knowledge, Skills, Abilities
- Excellent problem-solving skills, attention to detail, and ability to work independently and in a team environment.
- Knowledge of supplier development techniques and execution.
- Experience with quality inspection, auditing, and testing methods.
- Proficiency in MS Office software, eQMS and ERP systems.
- Strong analytical and problem-solving skills and quality analysis tools such Lean, 5 Why's, Pareto Analysis, SPC, FMEA, Six Sigma, etc.
- Strong verbal and written communication skills, with the ability to effectively communicate with suppliers, internal teams, and regulatory bodies.
Physical Requirements / Work Environment
Office and manufacturing environments, with occasional travel to supplier sites
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 exciting company culture that stands for integrity, intensity, involvement, and innovation!
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.
