Katalyst CRO · 2 months ago
Quality Engineer
Framingham, MA
Contract
Onsite
Mid LevelKatalyst CRO is a company focused on quality management in manufacturing. They are seeking a Quality Engineer to develop and maintain quality management systems, conduct audits, and ensure compliance with industry standards and regulations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO 13485, ISO 9001, and regulatory requirements including FDA regulations
Conduct regular quality audits across manufacturing processes to identify areas for improvement and ensure compliance with internal policies and external standards
Perform detailed quality inspections and control checks at various stages of production to verify product specifications and detect deviations
Collaborate with cross-functional teams to establish quality assurance protocols that support manufacturing efficiency while maintaining product integrity
Lead root cause analysis investigations for non-conformances or product defects; develop corrective and preventive actions (CAPA) to address issues effectively
Support validation activities for manufacturing equipment and processes in accordance with CGMP guidelines
Monitor key performance indicators related to quality metrics; prepare reports for management review
Facilitate training sessions on quality systems, regulatory compliance, and best practices for staff involved in production and quality assurance
Coordinate with suppliers and vendors during supplier qualification audits to ensure raw materials meet required standards
Participate in project management activities related to new product development or process improvements aimed at enhancing product quality
Maintain comprehensive documentation of quality procedures, audit findings, inspection reports, and corrective actions
Qualification
Required
Bachelor's degree in Engineering, Quality Management, or a related field; advanced certifications such as CQE (Certified Quality Engineer) are preferred
Proven experience in a Quality Engineer role within manufacturing environments, especially regulated industries such as medical devices or pharmaceuticals
Extensive knowledge of ISO 13485 standards for medical devices, FDA regulations (21 CFR Part 820), HACCP principles, CGMP practices, and ISO 9001 quality management systems
Strong background in conducting quality audits, inspections, and implementing QA/QC procedures
Familiarity with manufacturing processes including process validation and equipment qualification
Excellent analysis skills with the ability to identify root causes of issues quickly and develop effective solutions
Proficiency in using quality management software and data analysis tools
Effective project management skills with the ability to prioritize tasks efficiently
Strong communication skills to collaborate effectively across departments and with external partners
Preferred
advanced certifications such as CQE (Certified Quality Engineer)
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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