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Senior Design Assurance Quality Engineer
1 month ago
Senior Design Assurance Quality Engineer
POSITION SUMMARY: This position will be part of one or more product development teams where they will be responsible for contributing to the on-time development of high-quality products. This position will also be responsible for supporting and leading activities related to trending quality field performance. This position will be responsible for subsequent improvements for marketed products and optimization of design control processes as needed.
ESSENTIAL FUNCTIONS OF THE POSITION:
On time quality delivery of assigned product development team deliverables
Ensure assigned design control procedures are compliant with FDA, GMP, ISO, and other applicable standards and regulations.
Optimize existing processes to maximize efficiencies and continue to identify, plan, and execute continuous improvement activities.
Drive continuous improvements through observation, measurement and root cause analysis/resolution
Develop new processes which support speed, cost reductions, and quality improvements
Provide subject matter expertise for assigned processes to users as necessary.
Responsible for cross-functional collaboration with manufacturing operations, marketing, sales, regulatory, and clinical functions
Provide guidance for the development of manufacturing test/evaluation methods and process validation
Provides investigative support/leadership for product quality issues
Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls
Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity.
Serve as a technical resource for problem investigations to guide root cause analysis and corrective action development.
Provide mentorship to junior-level design assurance engineers in design control and product development
Ensure commitment to functional excellence and the ability to execute positive changes
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
BASIC QUALIFICATIONS:
Bachelor’s degree in Engineering required or demonstrated equivalent combination of education, training, and experience.
Minimum of 5 years of experience in an engineering role in the medical device industry
Experience with business process development
Working knowledge in statistical analysis techniques including Reliability assessment
Experience in test method strategies, development, and validation including GR&R
Experience with risk management methodology
Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
Ability to create and manage key internal and external partnerships
Excellent written and verbal communication skills
High level of attention to detail
Familiar with product safety and standards
Ability to demonstrate proficiency in issue resolution.
Ability to multi-task and work with little direction
Ability to manage multiple priorities
Familiar with product safety standards
Ability to travel 10%
PREFERRED QUALIFICATIONS:
7 years or more experience in an engineering role in Medical Devices
5 or more years’ experience working with Product Development
Experience in processes related to Design Change Control, Design Reviews, Requirements Management
Certification in ASQ, Six Sigma/Design for Six Sigma
OTHER REQUIREMENTS:
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
Ability to pass pre-employment drug screen and background check
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