Quality Assurance Specialist

Overview:

Are you passionate about quality and ready to take your career to the next level? Euclid Systems Corporation is seeking a driven Sr. Quality Specialist to play a key role in supporting and enhancing our Quality Management System (QMS). In this hands-on position, you’ll ensure compliance with industry regulations and standards while actively contributing to continuous improvement initiatives. You’ll gain valuable experience in complaint handling, CAPA management, training, and quality audits, all while working alongside a collaborative, cross-functional team. If you’re eager to grow and make a meaningful impact, we want to hear from you!

Key Responsibilities:

• Collaborate with multi-functional teams to implement quality improvements, including change requests, risk assessments, SOP reviews, and validation activities.
• Lead complaint investigations, manage returned lenses, and evaluate complaint reportability.
• Manage Corrective and Preventive Actions (CAPA), including investigations, root cause analysis, and corrective action planning.
• Review and update procedures to ensure ongoing compliance with regulations and customer requirements.
• Interpret standards and regulations to develop and refine policies, procedures, and processes.
• Oversee the implementation of Quality Assurance procedures and ensure data integrity and accuracy.
• Support and participate in internal, supplier, and external QMS audits; prepare and follow up on corrective action plans.
• Review and approve non-conformance reports (NCRs) and perform root cause evaluations.
• Assist management in maintaining quality and regulatory compliance across the organization.
• Prepare reports for QMS Management Review Meetings and monthly KPI meetings.
• Participate in cross-functional project teams focused on continuous improvement, non-conformances, complaints, and CAPAs.
• Ensure only finished products meeting acceptance criteria are released, through thorough review of final acceptance documentation.
• Maintain and manage training records.

 

Qualifications:

• Bachelor’s degree (BS) or at least 5 years of experience in quality and/or regulatory roles within a regulated environment (medical device, pharma, biotech, or life sciences).
• Minimum 5 years of hands-on experience with medical device complaint handling and CAPA management.
• Internal Auditor certification is a plus.
• Proven experience supporting internal and external audits.
• Demonstrated ability to deliver timely and accurate regulatory and quality deliverables.
• Strong knowledge of 21 CFR 820 and ISO 13485.

Skills:

• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office and electronic QMS (eQMS) systems.
• Exceptional organizational skills, with the ability to manage multiple assignments and prioritize effectively.
• Strong problem-solving abilities and attention to detail.

 

Why Join Us?

At Euclid Systems Corporation, you’ll be part of a team that values innovation, collaboration, and professional growth. If you’re ready to advance your career and make a real difference in the quality and safety of our products, apply today!