Overview

Senior Quality Engineer Jobs in Worcester County, MA at ClinLab Solutions Group

Title: Senior Quality Engineer

Company: ClinLab Solutions Group

Location: Worcester County, MA

Job Title: Quality Engineer / Senior Quality Engineer

Summary:

This contract-to-permanent position focuses on strengthening, sustaining, and improving the medical device Quality Management System (QMS) while supporting day-to-day manufacturing quality. The role is responsible for quality system remediation activities, including sterility assurance, controlled environment monitoring, CAPA, nonconforming product, calibration, supplier quality, complaints, audits, and documentation controls. The ideal candidate will be hands-on, with practical experience in medical device manufacturing and the ability to rebuild processes, close gaps, and transition remediated systems into stable routine operation.

Responsibilities:

  • Lead remediation and continual improvement of QMS processes, including CAPA, nonconforming product, and documentation controls, ensuring compliance with relevant standards and regulations.
  • Oversee sterility assurance and controlled environment monitoring, including EO sterilization process remediation, bioburden trending, and environmental monitoring programs.
  • Support day-to-day manufacturing quality activities, including production, inspection, MRB, root cause analysis, and product impact assessments.
  • Drive process validation and risk management improvements, collaborating on new product releases, IQ/OQ/PQ execution, and risk analysis documentation.
  • Manage calibration and preventive maintenance systems, including equipment tracking, investigations, and use-impact assessments.
  • Support supplier quality activities, including qualification, monitoring, corrective actions, and maintenance of supplier documentation.
  • Participate in internal and external audits, supporting audit readiness and compliance with FDA, Notified Body, and customer requirements.
  • Analyze quality trends, recommend process improvements, and ensure sustainable operation of remediated processes with defined metrics and review frequencies.

Qualifications:

  • 5+ years of hands-on Quality Engineering experience in an ISO 13485 medical device manufacturing environment.
  • Strong working knowledge of QMS processes, including CAPA, nonconforming product, complaints, internal audits, document control, DMR/DHR controls, change control, and risk-based decision making.
  • Demonstrated experience managing quality or operations-related projects, coordinating cross-functional resources, tracking deliverables, and driving actions to completion.
  • In-depth familiarity with EO sterilization and sterility assurance, including ISO 11135 concepts, sterilization validation, PCDs, biological indicators, and product impact assessments.
  • Calibration and metrology experience, including gage control, preventive maintenance, gage R&R, measurement uncertainty, and out-of-calibration assessments.
  • Supplier quality experience, including qualification, monitoring, audits, SCARs, incoming inspection, and performance trending.
  • Internal or lead auditor experience; experience supporting FDA, Notified Body, customer, or supplier audits.
  • Knowledge of controlled environment and environmental monitoring programs, including ISO 14644, viable air and surface monitoring, cleaning/disinfection controls, and cleanroom investigations.
  • Strong manufacturing quality background, including root cause analysis, containment, MRB support, process investigations, and production support.
  • Excellent technical writing, organization, follow-through, and cross-functional communication skills.
  • Statistical analysis capability, including SPC, trend analysis, sampling rationale, process capability, and data-driven quality decisions (highly desirable).
  • Experience with ISO 14971 risk management and integration into complaints, CAPA, NC, and product impact assessments (highly desirable).
  • Experience with MDR/Vigilance reportability support, complaint reportability assessments, or post-market surveillance (highly desirable).
  • Experience with process validation, test method validation, design controls, and manufacturing transfer activities (highly desirable).
  • Experience with electronic QMS, ERP, document control, training, or calibration management systems (highly desirable).
  • ASQ CQE, CQA, Lead Auditor, or similar professional certification (highly desirable).
  • Experience using Minitab, Excel, or similar tools for quality data analysis and trending (highly desirable).
  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; equivalent direct medical device quality experience may be considered.
  • Quality Engineer, Quality Auditor, Lead Auditor, or related certification preferred.
  • Hands-on, practical, and comfortable working directly with production, inspection, suppliers, and external service providers.
  • Able to organize ambiguous quality issues into clear plans, owners, due dates, evidence, and closure criteria.
  • Balanced judgment and ability to escalate issues appropriately.
  • Strong enough to challenge process gaps respectfully while helping the organization move forward.

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