Remote contingent worker (Michigan, Indiana, Ohio, Illinois preferred)
Job Description:
What you will do
The Staff Supplier Quality Engineer serves as a liaison between suppliers and Stryker to drive effective continuous improvement to the supply base. Works with internal customers and suppliers to support supplier quality issues and provide technical support for activities related to supplier quality system assessment, performance evaluation and quality improvement projects.
The Staff Supplier Quality Engineer collaborates with the strategic sourcing, auditing and development groups to understand capabilities and competencies of suppliers to fulfill quality and regulatory requirements.
Additional Responsibilities Include:
Assess and critique supplier processes and control documentation and drive improvement in the supplier QMS
Support tracking and reporting of KPIs and other metrics associated with supplier performance
Articulate detailed supplier performance results and trends to appropriate levels of management
Propose and develop effective quality improvement plans to be implemented at appropriate suppliers
Maintain and track completion of supplier action plans
Provide training and problem-solving expertise at Stryker sites and supplier locations, as needed
Identify and execute cost reduction opportunities at suppliers
Transfer lessons learned from the supply base to internal functions for inclusion into next generation designs
Train, mentor and assist in the development of less experienced engineers
Provide support in third party audits relating to supplier quality engineering deliverables
May act as a single point of contact for Strategic Business Partners and participate in supplier reviews
Serve as a subject matter expert, for assigned commodity; share expertise within global Stryker organization
Serve as a process owner and drive standardization of SQ-related processes
Additional duties, as assigned
What you need
Education / Work Experience
Basic Qualifications:
BSc / B. Eng. in a science, engineering or related discipline preferred, or equivalent years of experience
4%2B years of experience in quality, manufacturing, or a highly regulated environment
Lead Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable standard / regulation)
Preferred Qualifications:
ASQ CQE/CMQ/OE/PE certification
Demonstrated working knowledge to positively influence supplier quality performance
Lean Six Sigma Green Black Belt certification
Good knowledge of FMEA, validation programs and SPC processes
Good knowledge of manufacturing processes, prints, tolerancing, statistics and project management
Strong interpersonal skills, written, oral communication and negotiations skills
Knowledge and understanding of US and International Medical Device Regulations
Travel required
Additional Details from Intake Call:
Travel is required, contingent would be traveling for Stryker required audits (mostly across Midwest short trip, limited notice so needs to be flexible)
Remote contingent worker (Michigan, Indiana, Ohio, Illinois preferred)
In the beginning, role will be focused on collaborative work. Once trained, contingent will have autonomy in work but manager will be involved to ensure key KPIs are being met
40 hours weekly
Preference to candidates who have experience using TrackWise
Staff engineers will be set up with mentors and working with a team of 10 engineers (very tenured)
Top 4 Must haves:
MUST HAVE - Lead Quality Auditor Qualification (ISO 13485, CFR 820 or comparable standard / regulation) can be expired with experience at previous job but prefer active
Strong written and oral skills (will be representing Stryker during travel)
3-5 years Regulated industry experience required (order of preference -Medical, Pharma, Automotive)
3-5 years supplier facing experience
Top 4 would be nice:
Basic knowledge of FMEA, validation programs and SPC processes (statistic process controls)
Quality engineering experience
Understanding of manufacturing process
Understanding tolerancing
IV process:
Possible phone screening
2 rounds of IVs - 1 communication based, 1 technology based
Comments for Suppliers:
Remote contingent worker (Michigan, Indiana, Ohio, Illinois preferred)