Thermo Fisher Scientific
Type of industry, product or service:
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Staff Supplier Quality Engineer
Oakwood Village, Ohio
Requirements and Qualifications:
Location/Division Specific Information
This position offers an exciting opportunity for a highly motivated and experienced Supplier Quality professional. The role is located in Oakwood Village, OH and will have a key impact on the success of the Field and Safety Instruments (FSI) Business Unit.
Field and Safety Instruments (FSI) is a new business within Thermo Fisher that was established in 2017 by the merger of two legacy businesses. FSI is the leader in handheld spectrometers for a wide range of applications across industrial, pharma, safety/security, nuclear power, and healthcare markets.
How will you make an impact?
Due to the growth we’ve added this key role to our team in Oakwood Village, OH. You will drive our Supplier Quality Program to ensure that we’re able to meet the needs of our rapidly growing Field and Safety Instruments Business.
What Will You Do?
- Maintain and report meaningful supplier performance metrics to demonstrate the effectiveness of the supplier quality process and advising management of potential risks and make recommendations.
- Work closely with the Purchasing Team to select, qualify and develop suppliers by performing initial and periodic follow-up assessments/audits and assess suppliers against robust qualification requirements.
- Ensures the Supplier Quality function operates according to procedures and provides direction to other departments. Is a champion of problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐
- Review and approves supplier records including but not exclusive to: contracts, quality plans, change requests, CAPAs, NCRs, verification and validation protocols and reports.
- Act as Lead Auditor during supplier audits. Ensure management of supplier audits from planning to completion.
- Manage FAI (First Article Inspection) Process to ensure compliance to TFS requirements.
- Participate in design changes related to supplier provided materials. Partner with Purchasing to qualify new suppliers
- Drives continuous improvement with procedures, policies and quality assurance methodologies including but not exclusive to: new material qualification, end of life materials/components, product development process, supplier requests for material changes and sustaining engineering.
- Support the suppliers to ensure that products and processes comply with the relevant requirements
- Support Quality Management Team in establishing, implementing, and maintaining the quality management system for ISO 9001:2015.
- Assists in the development of procedures & processes in compliance with ISO & other external requirements
- 15-25% travel is required, depending on status of suppliers and supplier issues.
- Participate in the New Product Introduction process to assist with validation and test of critical components.
- Thorough understanding of ISO/QSRs and the ability to apply the knowledge to the business to ensure compliance to the regulations.
- Aware of and comply with TFS and associated Quality Manuals, regulatory requirements and most current world class best practices for the effective management and continuous improvement of supplier quality.
- Participate in PPI (Practical Process Improvement) and projects to support achievement of business metrics to drive improvement to the quality of our products and processes within Thermo Fisher Scientific but also at our key suppliers.
- Report on Key Performance Indicators (KPI’s) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.
How will you get here?
- S. Electrical or Optical Engineering required
Experience, Skills, Abilities
- S. Electrical or Optical Engineering required
- Minimum of 5 years’ experience in Supplier Quality Management
- Ability to focus on continual improvement practices using causal analysis tools to drive corrective and preventive actions.
- Must be a team player with strong interpersonal skills.
- Must be able to read and interpret engineering drawings
- Software Validation Experience required
- Strong knowledge in Printed Circuit Board Assembly and IPC-610 experience required
- Electro Mechanical Test Development Experience required
- Communicate effectively both verbally and written with supplier and internal personnel in a professional manner. Strong writing and facilitation skills. Function with little to no supervision.
- Must have experience performing and evaluation effective root cause analysis, corrective and preventive actions.
- ISO auditor training and certification preferred
- Lean Six Sigma Green or Black Belt certified preferred.
- Effective problem solving, root cause analytical skills to lead and influence others to drive change (cross-functionally and globally)
- ASQ Certified Quality Engineer
- Extensive ISO9001:2015 experience / auditor or lead auditor trained
- Detail oriented and has the ability to lead multiple projects and activities assigned