المسمى الوظيفي

Role overview

Prospect Life Sciences is seeking a Quality Engineer to take ownership of product and process quality across the organization. This role is responsible for managing key quality system activities such as CAPA, product returns and servicing, nonconforming materials, incoming, in-process, and final inspections, product complaints, environmental controls, and sterilization controls. The position reports to the Quality Assurance Manager.

Key accountabilities

The role is centered on three major areas: running and improving the quality management system, supporting day-to-day operations across functions, and helping deliver client projects and continuous improvement work.

Lead assigned quality management system processes with a focus on compliance, product quality, process effectiveness, and ongoing improvement.
Support manufacturing, supplier quality, sterilization, environmental monitoring, CAPA, complaint handling, inspections, and risk management activities.
Provide hands-on quality engineering support to Manufacturing, Product Development, Supply Chain, and Operations by identifying risks, adding process controls, assisting validation work, solving quality issues, and coaching team members.
Contribute to client projects by completing quality deliverables on schedule, reporting metrics accurately, and helping implement practices that improve quality, compliance, efficiency, and customer satisfaction.

Primary responsibilities

Own the CAPA process, including tracking, investigation support, verifying effectiveness, and ensuring internal and regulatory compliance.
Oversee product returns, servicing work, and complaint investigations in line with established quality procedures.
Take part in internal, supplier, customer, and regulatory audits, including preparation, attendance, corrective response development, and closure follow-up.
Investigate failures tied to nonconforming material, scrap, CAPAs, complaints, and manufacturing quality concerns to determine root causes and corrective actions.
Support supplier qualification, supplier monitoring, and improvement initiatives that strengthen supplier performance and compliance.
Maintain sterilization controls, environmental monitoring, cleanroom controls, and other assigned quality system processes.
Assist with receiving inspection, in-process inspection, and final inspection activities while ensuring adherence to procedures and acceptance criteria.
Support process validation, PFMEA creation, manufacturing readiness, and risk management in collaboration with Product Development and Operations.
Review quality records such as inspection logs, lot history records, calibration documents, sterilization records, and related documentation for accuracy and completeness.
Recommend and implement process improvements that strengthen the quality system, product quality, regulatory compliance, and operational efficiency.
Train and coach associates on quality procedures, control methods, inspection practices, and quality best practices.
Work closely with cross-functional teams to resolve quality issues and improve operational performance.
Partner with teams across the product lifecycle to support design transfer, validation work, and risk management.
Encourage clear communication and collaboration across functions to support quality goals and business success.
Pursue ongoing professional development beyond company-sponsored learning to expand technical knowledge and impact.
Support client projects by delivering quality engineering work according to schedules, budgets, regulatory needs, and customer expectations.
Analyze quality metrics, environmental monitoring data, and trend information to identify improvement opportunities.
Assist with project invoicing by preparing EOM/PR documentation accurately and promptly.
Join client meetings, technical discussions, implementation reviews, validation sessions, and project retrospectives as needed.
Drive continuous improvement by applying best practices, supporting Lean and quality improvement efforts, and incorporating feedback from clients and internal teams.

Education and experience

A bachelor’s degree in Engineering, Life Sciences, or another relevant technical field is required.
At least 5 years of progressive experience in FDA-regulated medical device quality management systems is required.
Experience with quality systems aligned to FDA QMSR (formerly 21 CFR Part 820 / QSR), ISO 13485:2016, ISO 14971, and other applicable domestic and international regulations is required.
Background in CAPA, nonconforming material handling, supplier quality, complaint investigations, sterilization, inspection, process validation, risk management, and internal audits is required.
Experience planning, conducting, or supporting internal, supplier, and process audits is required.
The selected candidate must be qualified as a PLS Internal Quality Auditor within 6 months of hire, or be capable of achieving that qualification within that timeframe, in line with ISO 13485:2016 and the PLS Internal Audit Procedure.

Additional qualifications

Strong analytical thinking, technical writing, communication, organization, and problem-solving abilities are needed.
Comfort using Microsoft Office, electronic quality management systems (eQMS), and ERP platforms is expected.
Experience in a Contract Development and Manufacturing Organization (CDMO) setting is preferred.
Exposure to Lean, Six Sigma, EOS, or other continuous improvement methods is preferred.
The ability to work well with cross-functional groups while independently managing multiple priorities is important.

Preferred certifications

ASQ Certified Quality Engineer (CQE), which is considered the most valuable for this role.
ASQ Certified Quality Auditor (CQA).
ISO 13485:2016 Internal Auditor or Lead Auditor certification.
Medical Device Single Audit Program (MDSAP) Auditor Training.
Lean Six Sigma Green Belt.
Certified Reliability Engineer (CRE), especially useful for process validation and failure investigations.

Work location

This is an onsite role based in the Denver Metropolitan Area.

Compensation and schedule

No salary or stipend amount was provided in the source material.

Quality Engineer