Overview
QA Inspector, 3rd shift Jobs in Lakewood, NJ at Renaissance Lakewood, LLC
Job Type: Part to full-time, hybrid on-site and remote
Note: This position is a job share with current QA/QMS Director
Description: The QA/RA Associate is responsible for maintenance of the quality system; product technical files and submissions, certification renewals, periodic updates and registrations to regulatory agencies; review of product and regulatory changes for impact on regulatory filings; research of regulatory issues to provide guidance and advice to senior management.
Specific Duties and Responsibilities :
Medical device product line responsibilities:
Maintenance of product technical files
Maintenance of current product approvals and registrations, including initiation of product testing as necessary to maintain approvals: sterilization, biocompatibility, shelf life stability, etc
New product submissions
Support of international distribution partners with required reports and documentation for product approvals and registrations in their markets
Post-market surveillance activities, including regulatory reviews of customer complaints and determination of regulatory reportability, advisory notice or recall as applicable
Advice to executive management on impact of regulation changes, strategies for compliance
Regulatory guidance to development project teams regarding design, development, evaluation, and marketing of products
Maintenance of company and product information in GUDID, and EUDAMED databases
Risk Management, incorporating new inputs into risk analysis and risk assessment
Review of labeling, advertising, and marketing materials for compliance to regulatory requirements
Quality management system responsibilities:
Establishment and maintenance of the quality system in compliance with the requirements of FDA QSR, ISO 13485, EU MDR.
Internal Audits
Preparation of Management Reviews, including compiling, analyzing, trending and presenting data and QMS metrics
Participation in vendor evaluation, selection, and performance evaluation.
Other duties as assigned
Requirements:
BA degree in a science or related field
Minimum 5 years’ experience in medical device regulatory affairs
Strong working knowledge of US and EU medical device regulations
Strong working knowledge and experience with quality systems regulations (FDA QSR, ISO 13485, EU MDR)
Self-Management: possesses integrity, flexibility, good use of time.
Good communication skills, both verbal and written
Effective project management and problem-solving skills
Good organizational ability and strong attention to detail
To apply please submit the following to [email protected]
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Title: QA Inspector, 3rd shift
Company: Renaissance Lakewood, LLC
Location: Lakewood, NJ
