À propos
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).
key 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 theorganization &/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 improvementrecommendations 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.
experience
4-7 years
skills
ISO/FDA 510K filing experience
qualifications
Top Candidates will also have:??? Bachelor???s Degree or Associate???s with experience preferred.??? Technical proficiency ??? must 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.
education
Associate
Compétences linguistiques
- English
Avis aux utilisateurs
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