As a Quality Engineer in Manufacturing, you will play a key role in ensuring that products are manufactured in compliance with internal quality standards, regulatory requirements, and our companys commitment to patient safety and product excellence. This position partners closely with Manufacturing, Operations, R&D, and Supply Chain to drive quality improvements and support continuous improvement initiatives on the production floor.
Responsibilities may include the following and other duties may be assigned:
Provide quality engineering support for manufacturing operations and engineering.
Support production, engineering, validation activities including training, reviewing and approving documentation, work instructions, SOPs , supporting risk assessments, to ensure compliance with regulatory and quality system requirements.
Lead and support investigations of nonconformances, deviations, and CAPAs, including root cause analysis and implementation of corrective and preventive actions.
Collaborate with cross-functional teams to identify, assess, and mitigate quality risks in manufacturing processes.
Support internal and external audits, including preparation, participation, and follow-up on audit findings.
Drive continuous improvement initiatives using quality and lean methodologies.
Ensure effective implementation and monitoring of process controls and quality metrics.
Support change management activities ensuring requirements are identified and executed when applicable.
Participate in Management Review and Quality Metrics reporting.
Responsibilities may include the following and other duties may be assigned:
Provide quality engineering support for manufacturing operations and engineering.
Support production, engineering, validation activities including training, reviewing and approving documentation, work instructions, SOPs , supporting risk assessments, to ensure compliance with regulatory and quality system requirements.
Lead and support investigations of nonconformances, deviations, and CAPAs, including root cause analysis and implementation of corrective and preventive actions.
Collaborate with cross-functional teams to identify, assess, and mitigate quality risks in manufacturing processes.
Support internal and external audits, including preparation, participation, and follow-up on audit findings.
Drive continuous improvement initiatives using quality and lean methodologies.
Ensure effective implementation and monitoring of process controls and quality metrics.
Support change management activities ensuring requirements are identified and executed when applicable.
Participate in Management Review and Quality Metrics reporting.
Requirements:
Bachelors degree in Engineering, Biotechnology, Life Sciences, or a related field.
Minimum of 7 years of experience in quality engineering or quality assurance of production in medical devices or pharmaceuticals.
Knowledge of quality systems and regulatory requirements (e.g., ISO 13485, FDA QMSR, MDR).
Strong analytical and problem-solving skills.
Ability to work effectively in a cross-functional, fast-paced manufacturing environment.
Hands-on experience with ECOs, nonconformance management, CAPA, and root cause analysis tools.
Familiarity with statistical tools and data analysis.
Experience supporting audits and inspections.
Knowledge of Lean, Six Sigma, or continuous improvement methodologies- advantage.
Strong communication skills in English, both written and verbal.
Bachelors degree in Engineering, Biotechnology, Life Sciences, or a related field.
Minimum of 7 years of experience in quality engineering or quality assurance of production in medical devices or pharmaceuticals.
Knowledge of quality systems and regulatory requirements (e.g., ISO 13485, FDA QMSR, MDR).
Strong analytical and problem-solving skills.
Ability to work effectively in a cross-functional, fast-paced manufacturing environment.
Hands-on experience with ECOs, nonconformance management, CAPA, and root cause analysis tools.
Familiarity with statistical tools and data analysis.
Experience supporting audits and inspections.
Knowledge of Lean, Six Sigma, or continuous improvement methodologies- advantage.
Strong communication skills in English, both written and verbal.
This position is open to all candidates.
