Senior Quality Engineer

Global Life Science Hub are in search of a Senior Quality Assurance Engineer. This dynamic position involves collaborating closely with the engineering and instrument manufacturing departments to ensure product quality and adherence to quality systems.

Key Responsibilities:

• Collect, analyze, and report quality metrics, and develop improvement plans as needed.
• Support process enhancements in Medical Device Software, Hardware, and Cybersecurity.
• Ensure timely resolution of internal and external audit findings.
• Collaborate with teams to create and implement action plans for CAPA, Complaint Investigations, and NCMRs.
• Produce quality reports to monitor cycle times, yield/quality rates, and identify trends using Pareto charts.
• Lead improvements in the Quality System, including requirement definition, system validation, process document updates, and user training.
• Conduct supplier assessments and enhance supplier monitoring through better trending, scorecards, and reporting.
• Identify and resolve process issues, determine root causes, implement corrective actions, and verify their effectiveness.
• Apply quality principles and problem-solving techniques to address design and manufacturing challenges.
• Support deviation activities related to processes and products, including tracking and trending.
• Investigate complaints, maintain records, and report trends.
• Review Device History Records (DHRs) and related documentation for accuracy, completeness, and compliance.
• Collaborate with the supply chain team to ensure supplier qualifications meet quality standards and regulatory requirements.
• Maintain open and effective communication with internal and external partners and vendors.
• Perform additional tasks as needed to support organizational quality and compliance.

Skills and Qualifications:

• Bachelor’s degree in an engineering-related field.
• At least 3 years of relevant experience in Quality Management within an FDA-regulated environment, ideally in the medical device or in vitro diagnostics industry.
• ASQ or Six Sigma Certification or equivalent is preferred.
• Strong knowledge of FDA Quality System Regulation (QSR) with a focus on Design Controls and/or medical device Cybersecurity.
• Familiarity with FDA IVD regulations and guidelines, and experience with FDA or notified body audits is highly preferred.
• Knowledge of current Good Manufacturing Practices (cGMP) and relevant international and FDA regulations.
• Experience with Quality Systems compliant with EN ISO 13485, ISO 14971, IVDR, and 21CFR Part 820.
• Proven track record of achieving results as part of a high-performing team, with the ability to collaborate effectively across the organization to maintain compliance and promote a quality mindset.
• Ability to read and interpret engineering drawings and component specifications, and use appropriate metrology methods for component inspection.
• Competence in interpreting technical instructions in mathematical or diagram form.
• Familiarity with relevant inspection techniques and equipment.
• Strong leadership abilities, including problem-solving, data collection, fact establishment, and statistical analysis.
• Excellent technical writing, statistical sampling, and data analysis skills; proficiency in Microsoft Excel.
• Demonstrated sense of ownership and accountability, with a results-oriented approach, urgency, sound judgment, and attention to detail.
• Flexibility and the ability to manage multiple competing priorities effectively. Strong communication skills across various organizational levels, with a positive, can-do attitude.
• A strong desire to cultivate a team-oriented and collaborative environment.

Apply:

The Global Life Science Hub is a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of pharmaceutical, CDMO, and CRO companies ranging from small start-ups to large global organizations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com