Analyst, Quality

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address can be reached on # .


We have Contract role Analyst, Quality for our client at St. Paul, MN. Please let me know if you or any of your friends would be interested in this position.

Position Details: Analyst, Quality- St. Paul, MN Location : St. Paul, MN 55112 (100% Onsite) Project Duration : 4-6 Months of contract with high probability of extension Shift : 8:00 Am - 5:00 PM (Mon-Fri) Pay Rate : $39.00 per hour on W2

Essential Functions:

• This position is for a Quality Analyst-Regulatory Compliance Specialist.
• This position will provide support to the Regulatory Compliance team and will assist with regulatory compliance activities.
• Under the direction of department management, this role performs a variety of tasks related to Regulatory Compliance and the Quality Management System (QMS)
• Ensure Regulatory Compliance records are accurate, complete, and maintained in accordance with applicable requirements.
• Prepare, review, and maintain quality system and regulatory compliance documentation and records.
• Maintain and update compliance-related database records.
• Support QMS document control processes.
• Assist with the creation, maintenance, and updating of training materials and training audiences.
• Identify discrepancies between metadata fields and approval records.
• Update required fields in Windchill to ensure alignment with approval records.
• Learn and effectively navigate electronic systems used to manage records and data.
• Demonstrate initiative to ensure work is completed accurately and thoroughly.
• Maintain organized, detailoriented work practices.
• Assist in the development and execution of streamlined business systems to effectively identify and resolve quality issues.
• Apply sound, systematic problemsolving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Support company initiatives as directed by management and in alignment with the Quality --Management System (QMS).
• Comply with U.S. Food and Drug Administration (FDA) regulations, other applicable regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive, professional communication and collaboration with employees, customers, contractors, and vendors at all levels.
• Perform other related duties and responsibilities as assigned.

Experience:

• 2 5 years of quality and/or regulatory experience, or
• 2 years of relevant industrial experience, typically within quality, product development/support, or scientific affairs functions.

Top Skills:

• Working knowledge of regulations and standards affecting medical devices.
• Strong attention to detail and organizational skills.
• Ability to learn new systems and processes efficiently.

Education:

• Bachelor s degree preferred in Biotechnology, Biology, Chemistry, Engineering, or a related scientific discipline.

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address can be reached on # .