Supplier Quality Engineer
Western DigitalSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare, ManufacturingIndustries
Requirements
- Good knowledge of GMP, ISO 13485, 21 CFR Part 820 standards
- Working knowledge of FMEA
Responsibilities
- Own Supplier related CAPA review and management, ensuring effective use of appropriate problem-solving tools
- Support tracking and reporting of KPI and other metrics associated with supplier performance
- Provide education and training to suppliers as necessary
- Articulate detailed supplier performance results and trends to appropriate levels of management
- Perform PPAP activities for supplier changes
- Perform detailed process reviews at supplier's manufacturing site
- Assess and critique supplier process control documentation, identifying areas of improvement and driving improvement within the suppliers QMS
- Communicate effectively to suppliers and internal stakeholders
- Maintain and track to completion closure of assigned supplier action items
- Collaborate with external/internal teams and stakeholders to prioritize supplier initiated change requests
- Develop and drive completion of personal development plans (IDP)
- Support PMO projects and initiatives
- Develop relationships with suppliers and internal cross functional partners
- Identify and execute on cost reduction opportunities through quality improvements at suppliers
- Manage and execute supplier initiated changes for continuous improvement, cost reduction or supplier remediation activities
- Analyze non-conformance data to prioritize projects and to solve systemic supplier issues
- Execute pro-active supplier site visits
- Transfer “lessons learned” from the supply base back to R&D for incorporation into next generation designs
- Provide problem solving expertise at supplier locations in support of critical quality issues
- Train, mentor and assist in the development of less experienced engineers
- Propose and develop effective quality improvement plans to be implemented at appropriate suppliers
- Provide support to 3rd Party Audits relating to Supplier Quality CAPA
- May act as a single point of contact for Strategic Business Partners and in some cases for Strategic Suppliers
- Serve as a subject matter expert, for assigned commodity; share expertise within global Stryker organization
- Lead or Oversee project portfolio of supplier improvement activities
- Collaborate with external/strategic partners to identify companywide opportunities for supplier improvement
- Oversee processes as a process owner and drive standardization of SQ-related processes such as PPAP, DPM, etc
- Serve as a liaison between suppliers and Stryker to drive effective continuous improvement to the supplier base
- Work with internal customers and suppliers to support supplier quality issues, provide technical support for activities related to supplier quality system assessment and performance evaluation
- Collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to fulfill product quality and regulatory requirements
Skills
CAPA
PPAP
KPI
QMS
Process Control
Supplier Audits
Root Cause Analysis
Non-Conformance Analysis
Continuous Improvement
Problem Solving
Data Analysis
Stryker
Develops and manufactures medical devices and equipment
About Stryker
Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.
Kalamazoo, MichiganHeadquarters
1941Year Founded
$423.3MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees