What we want:
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes
The Staff Supplier Quality Engineer serves a key role for supplier onboarding activities for both sustaining and merger & acquisition (M&A) quality support at Client. As a leader in achieving staggering growth through M&A and R&D, Client continues to set the pace to successfully integrate and bring disruptive technologies to operating rooms all over the world, every day. The Staff Supplier Quality Engineer interfaces with many functions of the business, both internal and external, including suppliers, quality, sourcing, regulatory, and operations, ensuring that the products and services provided by our global supply base continue to meet and exceed customer needs. Whether assessing supplier onboarding risks, evaluating suppliers of new or existing products, establishing agreements, or performing robust root cause investigations for NCs/CAPAs, the Staff Supplier Quality Engineer is focused on building quality into the products we sell.
What you will do:
- Collaborates with suppliers to assure the quality of their products, materials, components and/or operations.
- Monitors supplier performance and supports efforts to develop and implement changes to improve the production process.
- Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented.
- This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
Key Areas of Responsibility:
- Collaborates with cross-functional and suppliers' teams to address top quality issues.
- Own identified supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.
- Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
- Participates and may lead in the creation and/or review of new or modified procedures.
- Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
- Applies statistical methods of analysis and process control to external operations.
- Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
- Can work remotely, 25% Domestic Travel
- Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
- Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
- Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.
- Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.
- Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
- Deliver continuous improvement activities focusing on supplier quality.
- Participate in supplier audit program - planning, execution and closure.
- Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
What you will need:
- Bachelor's Degree
- 5+ years' experience in quality, engineering, manufacturing, or highly regulated environment
- Bachelor's or Master's Degree in Engineering or Science-related field
- Fluent in English & Mandarin.
- Understanding of US, EU and International Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Highly developed problem-solving skills. Strong analytical skills.
- Demonstrated ability to work independently and as part of cross-functional teams.
- Experience in working in a compliance risk situation.
- Computer literacy.
- Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.
- Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment.
- Lead Quality Auditor Qualification either in ISO 9001, ISO13485, CFR820 or comparable industry standards and regulatory requirements preferred.
- The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction.
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