Manufacturing Quality Engineer

Stark Pharma Solutions Inc; Geldern; Vor Ort; EUR 75.000 - 97.000; Vollzeit

Zusammenfassung

Stark Pharma Solutions Inc. is seeking a Manufacturing Quality Engineer to support manufacturing operations and ensure products and processes meet quality, regulatory, and customer requirements.

The role collaborates with Manufacturing, Engineering, R&D, Validation, and Quality teams to identify and resolve quality issues and drive continuous improvement in a GxP environment.

Qualifikationen

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences.
• 3–5 years in Manufacturing Quality or Quality Engineering.
• Experience in Medical Device/Pharma/Biotech manufacturing.
• Knowledge of GMP, FDA, ISO 13485, QMS.
• Experience with NCR, CAPA, Deviation, Change Control, RCA.
• Knowledge of PFMEA, SPC and process improvement.
• IQ/OQ/PQ activities experience.
• Familiarity with QMS/ERP systems (Veeva, TrackWise, MasterControl, SAP).

Aufgaben

• Support day-to-day manufacturing quality activities and production operations.
• Investigate NCRs, deviations, defects, and customer complaints.
• Perform root cause analysis using 5 Why, Fishbone, and other quality tools.
• Develop and implement CAPA and corrective/preventive actions.
• Support process validation and equipment qualification activities (IQ/OQ/PQ).
• Review and approve manufacturing processes, procedures, WIs, specs.
• Support Change Control and assess impact of changes.
• Monitor production quality metrics and identify improvement opportunities.
• Participate in PFMEA and risk assessments.
• Work with teams to reduce scrap, rework, defects, and variation.
• Support internal and supplier quality audits in GxP environments.
• Maintain quality records and documentation.
• Apply Lean/Six Sigma and SPC for performance improvement.
• Utilize ERP/QMS systems like Veeva, TrackWise, MasterControl, SAP.

Kenntnisse

Root cause analysis

Process quality improvement

GxP quality awareness

Documentation & compliance

Ausbildung

Bachelor's degree in Engineering/Quality/Manufacturing/Life Sciences

Tools

Veeva

TrackWise

MasterControl

SAP

Jobbeschreibung

About The CompanyStark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The CompanyStark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Job Title:

Manufacturing Quality Engineer

Location:

Delaware

Duration:

Long Term

Job Summary

We are looking for a Manufacturing Quality Engineer to support manufacturing operations and ensure products and processes meet established quality, regulatory, and customer requirements. The engineer will work closely with Manufacturing, Engineering, R&D, Validation, and Quality teams to identify and resolve quality issues.

Key Responsibilities

• Support day-to-day manufacturing quality activities and production operations.
• Investigate NCRs, deviations, defects, and customer complaints.
• Perform root cause analysis using 5 Why, Fishbone, and other quality tools.
• Develop and implement CAPA and corrective/preventive actions.
• Support process validation and equipment qualification activities, including IQ/OQ/PQ.
• Review and approve manufacturing processes, procedures, work instructions, and specifications.
• Support Change Control and assess the impact of process or equipment changes.
• Monitor production quality metrics and identify opportunities for improvement.
• Participate in process and product risk assessments, including PFMEA.
• Work with Manufacturing and Engineering teams to reduce scrap, rework, defects, and process variation.
• Support internal, supplier, and regulatory quality audits.
• Ensure manufacturing activities comply with FDA, GMP, ISO 13485, and company QMS requirements in GxP-regulated manufacturing environments.
• Maintain accurate quality records and technical documentation.
• Apply Lean Manufacturing, Six Sigma, SPC, and other process improvement and statistical quality tools to improve manufacturing performance.
• Utilize or support quality management and ERP systems such as Veeva, TrackWise, MasterControl, SAP, or similar platforms.

Basic Qualifications

• Bachelor s degree in Engineering, Quality, Manufacturing, Life Sciences, or a related field.
• 3 5 years of experience in Manufacturing Quality, Quality Engineering, or Process Quality.
• Experience in Medical Device, Pharmaceutical, Biotech, or Life Sciences manufacturing.
• Knowledge of GMP, FDA regulations, ISO 13485, and Quality Management Systems (QMS).
• Hands-on experience with NCR, CAPA, Deviation, Change Control, and Root Cause Analysis.
• Knowledge of PFMEA, SPC, process improvement, and quality tools.
• Experience with process validation and equipment qualification.
• Knowledge of IQ/OQ/PQ activities.
• Experience with Lean Manufacturing or Six Sigma methodologies.
• Familiarity with Veeva, TrackWise, MasterControl, SAP, or similar QMS/ERP systems.
• Experience working in a GxP-regulated manufacturing environment.
• Strong analytical, documentation, communication, and problem-solving skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.