Job Description

Who we want
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.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients lives.

What you will do

As a Senior Quality Engineer in working partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective.

You will serve as liaison between suppliers and Stryker to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation. You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.

This role will provide coaching and guidance to the SQE team to ensure compliance to technical, regulatory and Stryker requirements. This person will also act as the Single Point of contact for communication of issues for the suppliers within their commodity alignment.

Responsibilities:

* Work closely with operations and the business functions to ensure quality performance of product and processes.
* Collaborate with Divisional QA, cross-functional and suppliers teams to address top quality issues.
* Ownership for supplier quality performance and measurement including KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
* Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions.
* Lead CAPA projects and manage to timely root cause investigation, implementation and closure.
* Lead internal and supplier driven non-conformances and manage the timely closure of NC's.
* Apply statistical methods of analysis and process control to current operations in support of management review, CAPA, and other quality system processes
* Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers.
* Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc).
* 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 Global Quality Organization.
* Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
* Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
* Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
* Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
* Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.
* Deliver continuous improvement activities focusing on supplier quality.
* Support the creation and maintenance of inspection methods and sampling.
* Support the development and review of process and equipment validation/qualification and MSA of internal processes.
* Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier initiated changes.
* Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
* Participate as required in SCRB in conjunction with key stakeholders.
* Support assessment of supplier changes.
* Participate in supplier reviews for assigned suppliers as required.
* Participate in cross functional projects both locally & globally as required.
* Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.

What you need

Basic Qualifications:

* Bachelors Degree
* Minimum 3 years experience in quality, manufacturing or engineering

Preferred Qualifications:

* Technical Degree in relevant field desired
* Knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
* Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
* Demonstrated working knowledge to positively influence supplier quality performance
* Preferred industries are medical device, aviation, aerospace, automotive and defense
* Internal Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirement