Hi,
My name is Sravani Dasari, and I am a Talent Acquisition Specialist with
Stark Pharma Solutions, specializing in opportunities across the
Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.
I am actively connecting with professionals for current and
upcoming opportunities. If you are open to exploring new roles or would like to
stay informed about relevant positions, please send me your updated resume
along with the best number and time to reach you.
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Job Title: Quality Engineer
Location: Cambridge , MA
Industry: Medical Device / Pharmaceutical
Job Summary
We are seeking a highly motivated and detail-oriented Quality Engineer to support quality assurance and compliance activities within a GMP-regulated Medical Device and Pharmaceutical manufacturing environment. The Quality Engineer will be responsible for maintaining quality systems, supporting investigations, driving continuous improvement initiatives, and ensuring compliance with FDA, cGMP, ISO 13485, and company quality standards. The ideal candidate will work cross-functionally with Manufacturing, Validation, Engineering, and Regulatory teams to ensure product quality and patient safety.
Key Responsibilities
- Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO 13485 requirements.
- Review and approve deviations, non-conformances, CAPAs, and change controls.
- Conduct root cause investigations and implement corrective and preventive actions.
- Support internal, customer, and regulatory audits and inspections.
- Review manufacturing, validation, and quality documentation for compliance.
- Perform risk assessments and quality impact evaluations.
- Monitor quality metrics and identify opportunities for continuous improvement.
- Support supplier quality activities, including qualification and performance monitoring.
- Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle.
- Assist in process validation, equipment qualification, and product quality improvement initiatives.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, or a related field.
- 3+ years of Quality Engineering experience in Medical Device, Pharmaceutical, or Biotechnology industries.
- Knowledge of FDA regulations, cGMP, ISO 13485, and quality systems.
- Experience with CAPA, deviations, change control, and investigations.
- Strong problem-solving and root cause analysis skills.
- Excellent communication and documentation skills.
