Location: Portage, MI
Description: Our client is currently seeking a RAQA Project Associate for a 12 month + contract.
Support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification.
Key Areas of Responsibility:
• Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
• Engage in the development of optimum future state of QMS for business needs.
• Identify improvements and inputs into the quality planning process by analyzing data, assisting in compiling quality data and preparing reports.
• Execute development and/or modification of QMS.
• Support Change and Standards Board Review and related forums.
• Assess and quantify requirements for QMS requirements to optimize structure.
• Support GMP and GDP within Quality organization. Specifically support the Change owner in creation of ECRs, review incoming ECRs and at closing for correctness and completeness. Support Standards owner in Standards Assessment.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Support QMS training development and delivery.
• Contribute to the development, maintenance, and improvements of policies and procedures.
• Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.
• Support notified body communication.
• Ensure QMS reflects actual activities, business needs and supports NPD requirement.
• Participate in relevant QMS IS discussions.
• Basic project management understanding.
• Key contributor to QMS business process(es) and understand IS system support requirements.
• Support internal and external quality system audits.
• Understands system integration.
• Understand and maintain Standards Database as well as understand and use efficiently onePLM.
• Manage process description, order process and record management to Standards and International Regulations
• Follow-up on timely Change and Standards Assessment
Education / Work Experience:
• BS in a science, engineering, business or related discipline.
• 0+ years experience in manufacturing environment or equivalent.
Knowledge / Competencies:
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Basic knowledge of Quality Systems (Change Management, Standards Management, CAPA, audits, Quality Planning, etc.)
• Basic communication and project management skills.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Basic analytical and problem-solving capabilities.
• Demonstrated ability to work in cross-functional team environments.
• Computer literacy.
Additional Job Details:
• 3-5 years relevant work experience in the management of Quality System.
• Ideally, experience in the change management processes as a coordinator and/or reviewer of change orders/requests till the completion and closure
• Experience in a medical device field is desirable.
• Familiarity with US, European regulations and ISO 13485 standard.
Education: University Degree (BA degree) preferred or gained through equivalent work experience.
• Communication (verbal and written)
• Contributor to cross-functional activities
• Ability to work in cross-geographic environments
• Strong organizational and follow-through skills, as well as attention to detail.Contact:
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