Quality Engineer 3, Design Assurance

Teleflex•Maple Grove, MN

17h•$100,500 - $150,800

About The Position

The Quality Engineer III, Design Assurance is a member of a cross-functional team and is responsible for quality throughout new product development and improvement, through technology transfer and commercialization. The role ensures that applicable elements of the Quality System and external standards are followed. Serving as the voice of Quality, the engineer applies best-practice quality, team-based, and statistical tools and techniques and promotes their use throughout the organization. The position partners with functions including R&D, Marketing, Regulatory Affairs, Operations, Product Quality Assurance, Human Factors, and the PMO. It supports design controls, risk management, post-market surveillance, compliance, audits, test method development, CAPA, supplier quality, and regulatory submissions. The role applies these responsibilities at local, regional, and departmental levels and contributes to corporate technical programs.

Requirements

Bachelor of Arts or Bachelor of Science degree in a technical discipline such as engineering or science; equivalent experience may be considered.
Three to five years of quality engineering or design assurance experience; medical device industry experience is preferred.
Strong understanding of industry regulations and standards, including ISO 13485, ISO 14971, and FDA 21 CFR 820.
Proficiency in Microsoft Office and Minitab or other statistical software.
Strong organizational and time-management skills to meet deadlines while managing multiple projects.
Strong analytical and critical-thinking skills.
Proficiency in technical report writing and review.
Strong verbal and written communication skills.
Ability to foster a positive culture of growth, collaboration, and achievement across the organization.

Nice To Haves

ASQ certification preferred, such as CQE, CQA, CMDA, CRE, CSSGB, or CSSBB.
Experience in the medical device industry.

Responsibilities

Partner with R&D, Marketing, Regulatory Affairs, and Operations on product and process design activities, including design verification, validation, reviews, transfer, and design history file documentation.
Create and maintain product risk files, including risk management plans, hazard and risk analyses, failure mode and effects analyses, and risk management reports.
Periodically analyze post-market surveillance data and incorporate relevant findings into product risk files; support clinical and medical writers in analyzing available clinical data as required.
Use quality tools and statistical techniques to collect and summarize data, draw conclusions, determine sample sizes, apply distributions, identify relationships, calculate reliability, design and analyze experiments, assess process and performance capability, and support statistically based decisions.
Apply relevant quality philosophies throughout design control for new product development and sustaining activities, and manage work to minimize cost of quality over the product lifecycle.
Ensure practices comply with the Quality Management System, documentation is comprehensive, records are adequate, and change management is implemented.
Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
Partner with Product Quality Assurance and Operations to make risk-based decisions regarding nonconformances and technical complaints.
Interpret and apply applicable external regulations and internal standards; audit Design History Files and support internal and external audits.
Partner with Human Factors specialists and R&D to assess device usability throughout design and development.
Support development and validation of test methods; identify and apply metrology techniques, and conduct measurement system error studies such as Gage R&R.
Perform root cause analysis and identify appropriate corrective and preventive actions; use NC and CAPA systems as needed and oversee CAPA requirements, timeliness, effectiveness, phase status reporting, and technical reviews.
Support Regulatory Affairs with submissions, approvals, requests, and inquiries.
Define and apply product and process control methods, including control plans, essential design outputs, critical control points, and validated work instructions.
Apply producer and consumer risk concepts and interpret and select variable, attribute, and zero-defect sampling plans.
Apply supplier management principles and contribute to supplier selection, quality expectation letters, supplier quality agreements, and process qualifications.
Partner with the PMO to use project management tools to define deliverables and establish project schedules.
Contribute to corporate technical programs, including system improvement, remediation, and harmonization, in relevant areas.
Apply the role’s quality engineering concepts as needed at local, regional, and departmental levels.