Senior Supplier Quality Engineer at Olympus Corporation of the Americas in Missouri City, MO
Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. Let's inspire healthier lives, together. Job Description The Supplier Quality Engineer is responsible for developing, maintaining, and improving the supplier management process for the St. Louis (OVT) location supporting cross-functional project teams focused on proactive initiatives with OVT suppliers for legacy products and support of new products under development. Job Duties Lead cross-functional supplier management initiatives proactively focused on supplier development and driving continuous improvement activities across OVT suppliers. Qualifies suppliers according to OVT Quality Management System requirements. Maintain a risk-based Supplier Management process that includes development and trending of supplier metrics such as nonconformances, supplier corrective actions, and supplier audit results. Ensures that suppliers deliver quality parts, materials, and services. Evaluates and communicates quality issues to suppliers and applies systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation. Develops and prioritizes an auditing schedule to ensure that critical suppliers are audited on a regular basis to ensure good manufacturing practices and compliance with regulatory and OVT QMS requirements. Supports and collaborates with cross-functional new product development teams to qualify new suppliers. Creates and reviews quality plans, supplier quality agreements, component qualifications, and process validations. Job Requirements REQUIRED QUALIFICATIONS Bachelor's degree, or relevant experience. Minimum of 5 years of experience in medical device or other regulated industry. Some travel will be required (up to 20%). Some extended workdays may be required. PREFERRED QUALIFICATIONS Working knowledge of ISO 13485, 21 CFR Part 820, and other medical device industry US and international standards. Auditing experience in quality management system requirements (ISO 13485 or similar). ISO 13485 Certified Lead Auditor or CQA, preferred. Ability to work independently; organized and self-driven. Excellent written and verbal communication skills, including ability to communicate technical information. Problem solving abilities, applying statistical techniques to address issues and investigations. Ensure compliance to standards, regulations, and Company procedures. Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement. Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills preferred. Access, Visio, database, and statistical analysis software experience optimal.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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