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Quality Assurance Specialist

Redondo Beach, CA, United States

????????????????: Quality Assurance Specialist

????????????????????????????????: Redondo Beach, CA

Duration: 06 Months (Possible for Extension)

Position: 100% Onsite

Job Description

Assess device related complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required. Review and approve complaint files.

Maintain eQMS system and all document control activities

Support external audits (e.g. customer, corporate, notified body)

Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, and supplier questionnaires

Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners

Support the execution of the site's training program

Maintain Quality records according to Exelint International policies and procedures

Support timely delivery of products to customers with lot release and preparation of certificates of analysis

Support external regulatory agency audits, providing input to minimize potential for findings of non-compliance.

Participate in post-market surveillance activities for licensed products.

Assist in fulfilling requirements under the EU MDR 2017/745 transition.

Maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting.

Lead projects as needed by the quality department and participate in design control projects

Participate in internal audit program.

Other projects will be assigned as various business needs arise

Education

Bachelor’s degree or country equivalent in Engineering, Science, related scientific discipline, or equivalent.

Higher degree will be an advantage

Certifications

CQA, GMP certifications preferred

Experience, Skills And Technical Knowledge

Minimum of 2 years regulatory or equivalent experience within a medical device organization

Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.)

Prior experience with eQMS (Qualio, Greenlight Guru, etc…)

Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills

Excellent written and Verbal communication skills with the ability to listen, articulate and advocate

Proactive, high performance, result oriented and manage projects with ethical integrity

Technical system skills (e.g. MS office applications, databases, efficient online research)

Manage multiple projects and deadlines

Ability to identify compliance risks and escalate when necessary

Demonstrate both creative and critical thinking skills

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