Quality Assurance Specialist

2 weeks ago


Vista, California, United States Actalent Full time

Are you passionate about ensuring the highest standards of quality and compliance in the medical device industry?

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will play a critical role in facilitating audits with regulatory bodies, managing the 510k regulatory submission process, and collaborating with cross-functional teams to identify and mitigate risks.

Key Responsibilities:

• Facilitate audits with FDA and international regulatory bodies to ensure compliance with regulatory requirements

• Manage the 510k regulatory submission process, including compiling and submitting necessary reports and documentation

• Collaborate with Quality and Risk Management teams to identify and mitigate risks and issues

• File Vigilance Reports or Medical Device Reports (MDR) to Competent Authorities or the FDA

• Coordinate and facilitate submissions between departments to ensure timely and compliant regulatory activities

• Evaluate changes to regulatory documents and formulate strategies for proper filing categories

Requirements:

• 3+ years of experience in Quality Assurance/Regulatory Affairs (QA/RA)

• Excellent understanding of FDA and ISO regulations

• Bachelor's degree from a four-year college or university; or equivalent combination of education and experience

Preferred Skills:

• Knowledge of Database Software (EPDM), Spreadsheet Software (Excel), Project Management Software, Word Processing Software (Word), Electronic Mail Software (Outlook), and Presentation Software (PowerPoint)

What We Offer:

• Competitive salary: $85,000 - $110,000 per year

• Opportunities for growth and professional development

• Collaborative and dynamic work environment

• Recognition and rewards for outstanding performance

About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We believe in maintaining an inclusive environment through persistent self-reflection, building a culture of care, engagement, and recognition, and ensuring growth opportunities for our people.

Equal Opportunity Employer:

Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.



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