The Senior Global Supplier Quality Engineer will be responsible for developing and implementing processes across our global sites to enhance our supplier selection, development and monitoring processes. S/he will partner with our Global Procurement team to deliver on strategic initiatives. The Senior Global Suppler Quality Engineer will also work closely with site Quality teams to ensure harmonized Supplier Quality processes are implemented and effective, and serve the business, as well as meeting regulatory requirements. This person will develop and lead cross-site activities and drive best practice adoption.
Responsibilities & Qualifications
Tasks Summary & Responsibilities
- Maintain a thorough awareness of and ensure compliance with current international regulations pertaining to FDA QSRs and ISO13485.
- Be the process owner for, and coordinate, global Supplier Quality activities, including Supplier Audits, Supplier Reviews, multi-site supplier change coordination etc.
- Ensure that supplier selection and monitoring processes are effective.
- Develop multi-year Supplier improvement roadmaps with other stakeholders, and own execution of Supplier Quality aspects.
- Carry out audits to ensure compliance with regulatory and company requirements.
- Monitor trends and escalate to senior management as needed.
- Work with cross-functional teams to improve processes and procedures, and implement changes as driven by internal and external factors.
- Be the global subject matter expert for Supplier Quality aspects; support audit preparation, carry out training and ensure global sites are aware of the requirements.
- Work closely with Procurement to ensure processes and policies meet the regulatory and business needs.
- Monitor and measure performance of suppliers and report to management as required.
- Participate in Supplier Quality harmonization activities as new sites/businesses are acquired.
- Bench-mark and network within TE and outside the company to develop new ideas, and drive these to execution.
- Perform other job-related duties as assigned.
- Bachelor's Degree with a scientific or engineering emphasis.
- Minimum 10 years in a regulated industry, ideally in a multi-national medical device environment.
- Minimum 5 years Supplier Quality experience.
- Certified lead auditor.
- Ability to manage non-routine projects of moderate complexity.
- Knowledge and experience with FDA/GMP/QSR and ISO 13485.
- Excellent interpersonal skills – must be able to understand the opinions and perspectives of internal and external stakeholders and influence others without authority.
- Manage multiple tasks and accomplish them in a timely manner.
- Highly organized with strong ability to prioritize tasks and work on own initiative.
- Ability to evaluate information gathered from observation, experience, reasoning, and/or communication, demonstrated clarity, accuracy, precision, independent judgment and thoroughness.
- Willingness to travel domestically and internationally as needed (up to 10% of time)