Quality Engineer 3, Design Assurance

Teleflex•Maple Grove, MN

About The Position

As a member of a cross-functional team, the Quality Engineer III, Design Assurance 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. As the voice of Quality, the engineer applies best-practice quality, team-based, and statistical tools and techniques, and promotes their value and use throughout the organization. The position partners with R&D, Marketing, Regulatory Affairs, Operations, Product Quality Assurance, Human Factors SMEs, and the PMO to support product and process design, design controls, risk management, compliance, and project execution. It contributes to new product development and sustaining activities, post-market surveillance, regulatory submissions, audits, supplier management, and corporate technical programs.

Requirements

B.A. or B.S. degree in a technical discipline such as engineering or science; equivalent experience may be considered.
Minimum 3 to 5 years of quality engineering or design assurance experience.
Strong understanding of industry regulations such as ISO 13485, ISO 14971, and FDA 21 CFR 820.
Proficiency in MS Office and Minitab or other statistical software.
Strong organizational and time-management skills, including the ability 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

Quality engineering or design assurance experience in the medical device industry.
ASQ certification, such as CQE, CQA, CMDA, CRE, CSSGB, or CSSBB.

Responsibilities

Partner with R&D, Marketing, Regulatory Affairs, and Operations on product and process design activities, including design verification, design validation, design reviews, design transfer, and design history file activities.
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 update product risk files to reflect current risk profiles.
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 data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and support statistically based decisions.
Apply relevant quality philosophies throughout Design Control and related processes for new product development and sustaining activities, and manage work to minimize lifecycle cost of quality.
Ensure practices comply with the Quality Management System; maintain comprehensive documentation and adequate records, and implement change management.
Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
Partner with Product Quality Assurance and Operations on risk-based decisions related to nonconformances and technical complaints.
Understand applicable external regulations and internal standards, and apply them in daily work.
Audit Design History Files and support internal and external audits.
Partner with Human Factors SMEs and R&D to assess device usability throughout design and development.
Support test method development and validation; identify and apply metrology techniques, including calibration systems, traceability, measurement error, and control of standards and devices.
Conduct measurement system error studies such as Gage R&R.
Perform root cause analysis and identify appropriate corrective and preventive actions; use nonconformance and CAPA systems as needed.
Manage CAPA requirements, timeliness, and effectiveness; present phase status, progress, risks, escalations, and resource needs at CRB/ECRB meetings; review and disposition CAPA phases and extensions, and support technical reviews as needed.
Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
Define and apply product and process control methods, including developing control plans, identifying essential design outputs and critical control points, and developing and validating work instructions.
Apply producer and consumer risk concepts and related measures, including operating characteristic curves, AQL, LTPD, AOQ, and AOQL; interpret and select variable, attribute, and zero-defect sampling plans.
Apply supplier management principles and provide project input on 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, such as system improvement, remediation, and harmonization, in areas related to the role.
Apply the role’s quality engineering concepts as required at local, regional, and departmental levels.