OverviewThe Supplier Quality Engineer is responsible for supporting and maintaining Spacelabs quality programs across the supply chain (suppliers, service providers, contractors, etc.). This role will support execution for supplier quality to ensure supply base meets regulatory and industry standards according to Spacelab requirements and expectations.
This is a high-impact role that will support activities related to supplier quality and compliance (including qualification, approval, risk analysis, issue resolution, verification and validation efforts, etc.) associated with Spacelabs products. The individual will ensure compliant and effective execution of all quality processes and zealously drive and contribute to the safety and efficacy of company products.
The Supplier Quality Engineer will establish relationships across the supply chain in order to support supplier needs to support resolution of product issues and assist in identification of process improvement opportunities and to ensure safe and effective products and services.
Responsibilities- Collects and analyzes supplier performance to drive improvement and corrective action in the quality of materials / components sourced from suppliers; identify trends, drive corrective improvements, and report findings to management with quantified objectives.
- Evaluates supplier caused manufacturing yield issues, incoming quality issues, and field failures.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving the issues.
- Works cross-functionally in identifying and resolving technical issues.
- Executes audits of suppliers to assess compliance with regulatory and Spacelabs requirements, including audit scheduling, investigation and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
- Assess suppliers for technical, quality and manufacturing capabilities through direct on-site visits and technical discussions. Assists in the evaluation of proposed changes at suppliers.
- Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the department.
- Facilitate and partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration.
- Uphold the company's core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the company's Code of Ethics and Conduct.
- It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
Qualifications- Bachelor degree in Science or Engineering required.
- 5 + years of experience in manufacturing quality, engineering quality, or supplier quality (a combination of experience is acceptable).
- 5+ years of medical device industry experience.
- Working knowledge of quality process management and tools e.g. APQP, PPAP, SPC, process validation and verification, Statistics Tools and Analysis in development and revision of Quality Sampling Plans based on potential product and patient risk.
- Applied experience with ISO 13485 (Quality Management Systems), FDA medical device regulations, cGMP, and Risk Management (ISO 14971) to instil a culture dedicated to ensuring patient safety and sustained regulatory compliance.
- Additional applied knowledge of international standards and regulations preferred.
- Proficiency in data analysis, trending tools, and KPI/dashboard development; professional knowledge of statistical methods.
- Strong technical written and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in urgent circumstances.
- Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance.
- Ability to lead and influence cross-functional teams, including Procurement / Supply Chain, Regulatory Affairs, Service and Research & Development to drive reduction in patient safety risk and greater levels of regulatory compliance.
- Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans.
- Available for domestic and international travel up to 30%.
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Please review our benefits here: Life at OSIPay may range between $105,000 to $130,000 annually
The pay range above represents annual base salary only. Final compensation will be determined based on factors such as your job level, geographic location, date of hire, experience, job-related knowledge and skills, and education in conjunction with market and business considerations.
Base salary is one component of your total rewards package. You may be eligible for long-term incentives, potential discretionary bonuses, and the ability to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP). OSI also offers comprehensive benefits including various options for health plans, access to 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D insurance, leave of absence programs and an array of voluntary benefits. In addition, paid time off is offered to be used for vacation, holidays, bereavement, and jury duty. Full-Time salaried employees are entitled to flexible time-off.
