- 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.
- 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.
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Senior Quality Engineer - Lexington, United States - Global Life Science Hub
Description
Job Description
Job DescriptionGlobal 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:
Skills and Qualifications:
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 –
