Quality Assurance Specialist II

Position Overview:

The quality assurance specialist assists in ensuring that medical devices meet established quality standards and regulatory requirements. This role involves supporting quality assurance activities, quality management systems, R&D and design control processes, validation processes, product releases, document control, and compliance efforts.

Responsibilities:

• Support and comply with the company’s Quality Management System policies and procedures.
• Exercise excellent oral and written communication skills; strong attention to detail and record keeping skills.
• Perform batch release activities ensuring release decisions and documentation are completed in accordance to approved procedures, product requirements and regulatory compliance.
• Coordinates with the manufacturing department to perform line clearances and in-process verifications as needed.
• Review records for GMP compliance and consistency with company policies and procedures necessary to support customers’ quality requirements.
• Support Document Control including processing document changes, routing and maintaining training records.
• Support or manage quality events such as NCR, deviation, and CAPA processes to ensure records are appropriately initiated, investigated, reviewed and approved within the established timelines.
• Evaluate and
• Assess routine discrepancies or quality events for potential impact to released product, product disposition, validation status, regulatory compliance, and risk management, and coordinate resolutions or escalate issues for technical review or management review.
• Support traceability matrix (DHF, DMR, DHR) and validation records maintenance.
• Assist in the review and approval of design verification and validation activities and ensure these activities meet requirements and follow change control processes.
• Contributes to post market surveillance activities including complaint management.
• Perform incoming material inspections and release, document control processes and finished device releases.
• Assists in internal audits and support external audits and regulatory inspections.
• Participates in additional projects as assigned by management.

Qualifications:

• Bachelor’s degree in science or related field.
• Minimum of 2 years of experience with Quality Assurance in the medical device, biotech or related industry. Working knowledge of ISO 13485 preferred.
• Experience in R&D, design control or validation a plus.
• Excellent communication and interpersonal skills.
• Strong problem-solving abilities and attention to detail.
• Ability to work in a fast-paced and dynamic environment.