QUALITY ASSURANCE ASSOCIATE/ Medical Device

jalet associes; Philadelphia (Philadelphia County); On-site; USD 60,000 - 80,000; Full time

Job summary

jalet associes is seeking a Quality Assurance Associate in Philadelphia, dedicated to ensuring compliance and quality in medical devices. The ideal candidate will have 4-6 years of experience, a Bachelor's Degree, and skills in writing SOPs and quality documentation.

This position involves conducting audits, assisting with FDA inspections, and providing quality support to both internal and external clients.

Qualifications

• 4-6 years related experience preferred.
• Experience working with medical devices is essential.
• Writing and reviewing quality assurance related documents required.

Responsibilities

• Write and review SOPs and quality documents.
• Maintain control documents in Quality Assurance.
• Assist in internal quality audits and documentations.
• Perform investigations on non-conformances.
• Provide GCP/QA support to clients.

Skills

Ability to work independently

Exceptional communication skills

Advanced computer knowledge in MS Office

Experience in a regulated environment

Experience with FDA inspections

Education

Bachelor's Degree in related field

Job description

QUALITY ASSURANCE ASSOCIATE/ Medical Device

Job Type: Full-time

Our client is a medical device company dedicated to offering innovative solutions for the treatment of chronic heart failure. The Company’s developments are based on its proprietary technology for administrating Cardiac Contractility Modulation therapy.

Responsibilities

• Write and review of SOPs and other quality assiuance related technical data forms and quality documents
• proper maintenance of control documents in Quality Assurance
• Control documents to differents departments
• Review validation protocols for GMP compliance
• Assist in carrying out internal quality audits on company systems and documentations
• perform investigations on non-conformances and customer complaint close out and corrective actions
• Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines
• Provide GCP/ QA support and avdvice to internal and external clients
• Ensure the timely and effective follow up to all identified or assigned quality issues
• Maintains and demonstrates understanding of global standards, regulation and regulatory bodies to include but not limited to ISO13485, 21FR; part 820 AIMD
• Assist in the maintenance ogf Quality Management System under direction of Director, Quality Assurance
• Participate in Mock inspections for FDA inspection preparation

Qualities & Qualifications

• Ability to work independently with little or no supervision
• Exeptional oral and written communication capabilities
• Advance computer knowledge in MS Office programs
• Bachelors's Dregree in related field
• 4-6 years related experience
• Experience working in regulated environment with medical devices
• Experience with FDA inspections and /or Notified Bodies Audits desirable

All your information will be kept confidential according to EEO guidelines.