Quality Engineer IV

Medical Engineering Consultants (MEC); Arden Hills (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Medical Engineering Consultants (MEC) in Arden Hills, MN, is seeking a senior specialist to develop and improve post-market surveillance and complaint trending methodologies to support product quality, patient safety, and regulatory compliance.

You will partner with Quality, Regulatory, Clinical Engineering, and Risk Management to provide data-driven insights, build analytical tools and dashboards, and advance predictive analytics and SPC applications across the product lifecycle.

Qualifications

• Education: Bachelor's degree in Statistics, Mathematics, Computer Science, Engineering, Data Science, Analytics or related field.
• Experience: 8+ years in advanced analytics tool development or post‑market surveillance in a regulated industry.

Responsibilities

• Perform complaint monitoring and statistical trending to identify product quality and patient safety concerns.
• Conduct signal assessments and present findings to cross-functional teams.
• Develop and improve complaint monitors aligned with risk management docs.
• Create Power BI dashboards and analytical tools for post-market surveillance.
• Apply SPC techniques to evaluate product performance and trends.
• Collaborate with Risk Management to ensure surveillance aligns with product risks.
• Support audits and continuous improvement initiatives.

Skills

Advanced analytics

Statistical modeling

Post-market surveillance

Education

Bachelor's degree in Statistics/Mathematics/Computer Science/Engineering/Data Science/Analytics

Job description

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages. MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill‑set Engineering staff and SME’s (Subject Matter Experts). MEC’s mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Job Description

Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. Client is not able to consider candidates who require sponsorship. Interview process: 2 rounds Onsite- Arden Hills Job Summary Develops maintains and continuously improves post-market surveillance and complaint trending methodologies tools and processes to support product quality patient safety and regulatory compliance. Performs statistical analyses signal evaluations and complaint monitoring activities to identify emerging risks and product performance trends. Partners with Quality Regulatory Clinical Engineering and Risk Management stakeholders to provide data-driven insights that support decision making across the product lifecycle. Serves as a technical resource for post-market analytics statistical process control visualization development and risk-based monitoring approaches. Supports the development and maintenance of analytical tools dashboards and automated solutions to enhance post-market surveillance effectiveness and efficiency.

Key Responsibilities

• 1. Performs complaint monitoring statistical trending and signal evaluation activities to identify emerging product quality and patient safety concerns.
• 2. Conducts signal assessments and presents findings recommendations and escalations to management review boards and cross-functional stakeholders.
• 3. Develops maintains and improves complaint monitors aligned with risk management documentation product hazards and surveillance requirements.
• 4. Executes ad hoc data analyses to support Quality Regulatory Clinical Engineering and business partner requests.
• 5. Creates maintains and validates Power BI dashboards visualizations reports and analytical tools.
• 6. Applies statistical methodologies and Statistical Process Control SPC techniques to evaluate product performance and identify meaningful trends.
• 7. Collaborates with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post‑market requirements.
• 8. Supports continuous improvement initiatives through automation data visualization and process optimization efforts.
• 9. Investigates data anomalies and develops recommendations to improve data quality monitoring effectiveness and signal detection capabilities.
• 10. Communicates analytical findings to both technical and non-technical audiences through clear visualizations presentations and written summaries.
• 11. Supports audit readiness and compliance with applicable quality system and regulatory requirements.
• 12. Contributes to the development of innovative analytical approaches including machine learning techniques predictive analytics and advanced statistical methodologies where appropriate.

Quality Systems Duties and Responsibilities

Build Quality into all aspects of work by maintaining compliance with all quality system requirements internal procedures applicable regulations and company standards.

Qualifications Required

• Education Bachelor's degree in one of the following disciplines:
• Statistics
• Mathematics
• Computer Science
• Engineering
• Data Science
• Analytics or related technical field
• Required Experience - 8 years of experience with advanced analytics tool development statistical modeling or post‑market surveillance within a regulated industry.

• Sponsorship is not available for this position

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.