Quality Engineer - Medical Devices & Process Excellence

Banque Internationale à Luxembourg (Suisse) SA; Pasco (WA); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, and Vision benefits

HSA contribution matching

401(k) – employer match details

LTD, STD, and Life Insurance plans

Job summary

Permobil has a position open for a Quality Engineer in Pasco, WA. The role focuses on ensuring product quality, handling non-conforming material, and applying risk management to design and manufacturing processes.

Candidates should have a bachelor's degree in engineering and 2 years of related experience, familiarity with medical device regulations (21 CFR Part 820) and ISO 13485, and proficiency in MS Office. Permobil offers competitive compensation and comprehensive benefits.

Qualifications

• Bachelor's degree in engineering and 2 years related experience.
• Familiarity with medical device regulations (21 CFR Part 820) and ISO 13485 preferred.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Experience implementing continuous improvement activities (Kaizen, 5S, Layered Process Audit) preferred.
• Excellent communication skills and ability to work with a cross functional team.

Responsibilities

• Investigating non-conforming material and determining disposition; determining characteristics critical to quality and safety based on product drawings, risk management documentation and feedback from appropriate departments; determining acceptance criteria and inspection methods and frequency for raw goods, components, and finished products; assessing the impact of uncalibrated or out of tolerance measuring equipment; and utilizing appropriate standards for determination of sample size and frequency.
• Understanding how requirements laid out in ISO 14971 and government regulations for risk management apply to company products and processes; supporting formal risk management activities as a member of the risk team; and utilizing risk management tools such as FMEA, Hazard Traceability Matrix, Fault Tree Analysis, and Root Cause Analysis.
• Managing and analyzing data for products; tracking the impact of product and process changes on product quality; participating in Lean and Six Sigma activities, Kaizen events, and other improvement initiatives; presenting reports to appropriate department managers; and providing feedback to leadership.
• Identifying and educating others on regulations and standards applicable to the product and manufacturing process; evaluating processes, change requests, and deviations against regulatory requirements; and supporting internal and external audits.
• Attending educational workshops, seminars, and conferences; reviewing professional publications; and maintaining familiarity with current company products and technology.
• Monitoring and reporting on Production Line quality including but not limited to quality of components, quality performance of products manufactured on production lines; Coordinating improvements with operations supervision; communicating external supplier nonconformities to Group Supply Chain for resolution; and managing quality of internal suppliers.
• Other duties and responsibilities as assigned. Duties and responsibilities may change from time to time.

Skills

Excellent communication

Analytical thinking

Statistical analysis

Cross-functional teamwork

Education

Bachelor's degree in engineering

Tools

Microsoft Office

Job description

Permobil has a position open for a Quality Engineer in Pasco, WA. The role focuses on ensuring product quality, handling non-conforming material, and applying risk management to design and manufacturing processes.

Candidates should have a bachelor's degree in engineering and 2 years of related experience, familiarity with medical device regulations (21 CFR Part 820) and ISO 13485, and proficiency in MS Office. Permobil offers competitive compensation and comprehensive benefits.