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 –