Senior Quality Engineer

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Post-Market Surveillance & Complaint Trending Location:

Hybrid (3 days onsite per week)

Compensation :

$60

•75/hour W2

Citizenship Requirements:

U.S. Citizens, Green Card Holders, and TN Visa holders only. No H1B, OPT, EAD, or F1 sponsorship available. 6+ Month Contract

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•Hire Overview Entegee is seeking a Senior Quality Engineer to support product complaint monitoring, post-market surveillance, and product performance trending activities. This role plays a critical part in ensuring product quality, safety, and regulatory compliance through the development and maintenance of complaint monitoring strategies, signal detection methodologies, and data-driven quality assessments.

The ideal candidate will possess a strong background in medical device quality systems, complaint handling, reliability analysis, and statistical evaluation of product performance data. Key Responsibilities Develop, maintain, and improve product complaint monitoring and trending strategies. Analyze complaint data, product performance information, risk profiles, and lifecycle data to establish effective monitoring methodologies. Define and document product-specific complaint trending criteria and supporting statistical rationale. Perform complaint trending analyses and investigate potential signals, anomalies, and emerging product performance concerns. Partner with cross-functional teams including Quality, Regulatory Affairs, Clinical, Manufacturing, Engineering, and Product Development. Create technical reports, engineering assessments, justifications, and quality documentation supporting monitoring decisions. Reassess existing monitoring approaches to ensure continued effectiveness and regulatory compliance. Support continuous improvement initiatives related to complaint monitoring and post-market surveillance processes. Participate in audits, inspections, and quality system activities. Serve as a technical resource regarding complaint trending methodologies, signal detection, and post-market performance evaluation. Lead or support cross-functional projects and mentor junior team members as needed. Required Qualifications Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related technical field. 7+ years of experience in: Medical device quality Post-market surveillance (PMS) Complaint handling Complaint trending Product performance monitoring Reliability engineering Quality engineering or closely related functions Experience developing, evaluating, or maintaining complaint monitoring, trending, or signal detection methodologies. Working knowledge of statistical concepts and their practical application to quality and product performance monitoring. Strong technical writing skills with experience documenting rationales, engineering assessments, and quality decisions. Experience collaborating with cross-functional stakeholders in Quality, Regulatory, Clinical, Manufacturing, and Engineering environments. Advanced Microsoft Excel skills. Strong analytical, organizational, project management, and problem-solving capabilities.

Preferred Experience Familiarity with:

Statistical Process Control (SPC) Control charts Trend detection methodologies Quality engineering tools and techniques

Knowledge of:

FDA post-market surveillance requirements Medical device complaint handling regulations EU MDR post-market surveillance activities Quality system compliance requirements Experience supporting audits, inspections, and regulated quality systems. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPA Pay:

$60.00

•$75.00 per hour Expected hours: No less than 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Life insurance Vision insurance People with a criminal record are encouraged to apply

Work Location:

Hybrid remote in Minneapolis, MN 55447