Job Description

Description

We are looking to recruit a Quality Assurance/Regulatory Affairs Specialist for a growing and innovative medical device manufacturer. This is an on-site position in York, PA (5 days a week).
Summary of position

Under the supervision of the Director, Quality/Regulatory, the QA/RA Specialist is responsible for the maintenance and management of policies and procedures that ensures quality compliance to HR's Quality System, based on federal Quality System Regulation 21 CFR 820. The QA/RA Specialist role will support both Quality and Regulatory functions to contribute towards accomplishment of department and organizational objectives.

Duties & Responsibilities

• Provide support with corrective/preventive actions and nonconformances to ensure closure in a timely manner
• Report to management on the performance of the quality management system and any need for improvement to comply with regulatory standards
• Work with product development, sales, and management to ensure timely approval of new products and continued regulatory support of marketed products
• Supports the design control / change control process with input on quality and regulatory requirements
• Evaluate potentials risks of nonconforming product and complete risk assessments
• Assist with supplier quality management program including supplier evaluations, approvals, and ensuring continued their compliance through supplier surveillance activities
• Conduct internal and supplier quality audits, as needed
• Collection of post-market surveillance data (complaints, adverse events, etc.) for regulatory reporting and trending
• Assist with customer complaint investigations
• Review/interpret regulatory requirements for domestic and international markets
• Ensure organizational compliance to governmental standards and other standards as deemed necessary by the organization. These include, but not limited to, EU Medical Device Regulation, ISO 13485, 21 CFR 820, and 21 CFR 210/211
• Draft and maintain quality management documentation, including procedures, work instructions, plans, etc. as needed for compliance
• Review new and revised artwork for regulatory compliance and participate in artwork approvals
• Support FDA, third party, and customer audits, as needed
• Promote an environment of compliance to internal policies/procedures and quality first mindset
• Complete additional projects and tasks, as assigned

Qualities

• Commitment to the organization's values and objectives
• Strong verbal and written communication skills
• Willingness to learn
• Energetic team player with a pleasant demeanor
• Ability to work in fast-paced environment
• Excellent attention to detail
• Ability to prioritize tasks
• Dependable and timely to work

Qualifications

• Bachelor's Degree required
• 1-3 years' Quality Assurance or Regulatory experience working in FDA regulated industry
• Knowledge of ISO 13485 preferred
• Experience in MS Office applications

TSP Talent Solutions and our customers are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)