Supplier Quality Engineer

Spacelabs Healthcare; Snoqualmie (WA); On-site; USD 105,000 - 130,000; Full time

Benefits offered by this job

401(k) retirement plan

Health Savings Account

Disability insurance

Flexible time-off

Job summary

Spacelabs Healthcare is searching for a Supplier Quality Engineer in Snoqualmie, WA, to enhance quality in medical device production. Candidates should have a Bachelor’s degree in Science or Engineering and over 5 years of relevant experience. Your responsibilities will include collecting supplier performance data, auditing, and ensuring compliance with ISO regulations. The salary ranges between $105,000 and $130,000, along with comprehensive benefits like health plans, 401(k), and stock purchase opportunities.

Qualifications

• 5+ years of experience in manufacturing quality or supplier quality.
• 5+ years of experience in the medical device industry.
• Proficiency in statistical methods and KPI/dashboard development.

Responsibilities

• Collect and analyze supplier performance data.
• Evaluate supplier-caused manufacturing yield issues.
• Conduct audits of suppliers to assess compliance.

Skills

Data analysis

Quality process management

Technical communication

Multi-tasking

Team leadership

Education

Bachelor’s degree in Science or Engineering

Tools

ISO 13485

FDA medical device regulations

APQP

PPAP

SPC

Job description

Overview

At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better‑informed decisions, increase efficiencies, and create a safer environment for patients.

Supplier Quality Engineer Responsibilities

• Collect and analyze supplier performance to drive improvement and corrective action in the quality of materials and components sourced from suppliers; identify trends, drive corrective improvements, and report findings to management with quantified objectives.
• Evaluate supplier‑caused manufacturing yield issues, incoming quality issues, and field failures.
• Apply sound, systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve issues.
• Work cross‑functionally to identify and resolve technical issues.
• Execute audits of suppliers to assess compliance with regulatory and Spacelabs requirements, including audit scheduling, investigation and evaluation of audit observations and findings, reporting, follow‑up, and confirmation of corrective actions.
• Assess suppliers for technical, quality, and manufacturing capabilities through direct on‑site visits and technical discussions; assist in evaluating proposed changes at suppliers.
• Review and approve supplier corrective action plans and verify effectiveness documentation.
• Establish and maintain business relationships to facilitate assignment completion; interact with suppliers, determine project goals and objectives, and may lead projects within the department.
• Facilitate and partner with suppliers to develop strong business and quality relationships, ensuring clear 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.
• Report quality problems or defects to management to implement corrective action and prevent recurrence.
• Duties may be modified or assigned at any time to meet business needs.

Supplier Quality Engineer Qualifications

• Bachelor’s 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, verification, statistics, and development of Quality Sampling Plans based on product and patient risk).
• Applied experience with ISO 13485, FDA medical device regulations, cGMP, and Risk Management (ISO 14971).
• Additional applied knowledge of international standards and regulations preferred.
• Proficiency in data analysis, trending tools, KPI/dashboard development, and statistical methods.
• Strong technical written and verbal communication skills; able to work effectively across all levels of a global organization and remain composed in urgent circumstances.
• Proficiency in multi‑tasking in a high‑paced, matrixed environment with awareness of compliance and operational impact.
• Ability to lead and influence cross‑functional teams, including Procurement / Supply Chain, Regulatory Affairs, Service, and Research & Development to reduce patient safety risk and enhance regulatory compliance.
• Organized, resourceful, with excellent attention to detail and ability to execute on assigned project plans.
• Available for domestic and international travel up to 30%.

Benefits

Pay may range between $105,000 to $130,000 annually. The pay range represents annual base salary only; final compensation is determined by factors such as job level, geographic location, date of hire, experience, and education.

Base salary is one component of total rewards; employees may be eligible for long‑term incentives, discretionary bonuses, and the opportunity to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP). OSI offers comprehensive benefits, including health plans, a 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D, leave of absence programs, and voluntary benefits. Paid time off for vacation, holidays, bereavement, and jury duty is provided; full‑time salaried employees are entitled to flexible time‑off.

Equal Opportunity Employer - Disability and Veterans

Know Your Rights: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf