qa coordinator.

We are seeking a detail-oriented and experienced Quality Assurance Coordinator to be a pivotal player in maintaining our high standards for quality, safety, and regulatory compliance. In this role, you will be the central hub for quality-related data, managing documentation, preparing reports, and driving process improvements. A key part of your responsibility will involve coordinating the team's preparation for critical external reviews, including FDA Examinations and ISO Certifications. You will actively analyze performance data, investigate customer feedback and product issues, and implement corrective actions. The ideal candidate has strong analytical skills, a solid understanding of quality management systems, and the authority to make critical determinations regarding product quality and process changes to ensure we consistently meet all FDA standards and internal policies.

Responsibilities:

• Quality Assurance Coordinator (duties include but are not limited to the following):
• Collects, monitors, organizes, and distributes information related to quality and process improvementfunctions, including the preparation & filing of quality system reports.
• Coordinating the team with FDA Examination & ISO Certification representatives, including being apart of the team that prepares FDA & ISO submission and certification documents.
• Generate reports using computer skills and distributes those reports to various users in the organization &/or among customers and suppliers.
• Analyze customer feedback, product failures/returns and developing/implementing corrective actions.
• Evaluate the Quality Management Systems of new and existing suppliers, make improvement
• recommendations and monitor quality performance of existing suppliers.
• Make determinations regarding acceptable or questionable product. Solicit judgment from Managersas needed.
• Analyze statistical data from vendors when necessary to ensure materials meet specifications.
• Ensure compliance with applicable FDA standards and procedures.
• Enforce safety rules, work rules and other plant policies and procedures.
• Have the authority to place product on hold and determine process changes.

Working hours: 7:00 AM - 4:00 PM

Skills:
ISO/FDA 510K filing experience

Education:
Associate

Experience:
4-7 years

Qualifications:
Top Candidates will also have:

• Bachelor's Degree or Associates with experience preferred.
• Technical proficiencymust be able to use computers & generate reports.
• Ability to create product inspection plans & develop test procedures
• Ability to respond to inquiries or complaints from customers, regulatory agencies or members of thecommunity.
• Background in Manufacturing Quality, Supplier Quality or Customer Quality is a plus.

Apply at www.spherion.com/apply/75102

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including health, and an incentive and recognition program (all benefits are based on eligibility).

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).