Principal Operations Quality Engineer
Principal Operations Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Subject Matter Expert serving as core Operations Quality Engineer for new and current products while applying comprehensive knowledge of lean six sigma and quality engineering principles six sigma black belt design for manufacturability (DFM) and problem solving (RCA) techniques to ensure the highest level of product quality.
Responsibilities:
Lead in crossfunctional teams to ensure process qualification/validation methods are aligned with industry best practices and applicable standards.
Work with Operations to ensure the optimization of manufacturing processes using engineering principles such as Six Sigma and Lean methods.
Lead investigations of product quality and compliance issues related to NCRs and CAPAs including analyzing results and making recommendations.
Recommend test methods and statistical process control (SPC) for achieving required level of product quality.
Represent Operations Quality Engineering during the design transfer process for R&D programs.
Develop and coordinate technical studies and design of experiments (DOE) as necessary to improve product quality.
Develop statistical models to identify products or processes posing excessive failure risks.
Propose improvements as necessary in process design and process controls to achieve a high level of product quality and process yield.
Develop technical content of risk management files related to Operations.
Review engineering change orders for impact on specifications product quality and compliance.
Apply sound systematic problemsolving methodologies in identifying prioritizing communicating and resolving quality issues.
Conduct supplier process audits and support activities to resolve audit findings.
Support all initiatives as identified by management in improving Quality Management Systems (QMS) and other regulatory requirements.
Mentor and Provide Guidance to Junior Engineers on RCA and Operational best practices
Support and Partner with counterparts for continuous improvement efforts especially for new equipment or improved processes.
Perform special projects as assigned.
Qualifications:
Bachelors degree in Engineering or Technical field.
Prior medical device manufacturing and quality engineering experience.
Thorough knowledge of advanced statistics and problemsolving techniques.
Strong Track Record working in Operations Environment on DaytoDay activities
Minimum 8 years experience in product realization in medical devices.
Excellent verbal and written communication skills.
Detail oriented; deliver high quality product consistently and on time.
Thrive in a fastpaced and dynamic work environment.
Computer skills including statistical/data analysis and report writing skills. Certification in Six Sigma Black Belt / ASQ certification preferred.
Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $115000.00 $144000.00. A range of factors including location skills and experience will be considered. Actual compensation may vary.
#LIONSITE
Inari Medical is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Required Experience:
Staff IC
Employment Type
Full-Time
