We are seeking a high-caliber Quality Assurance (QA) Manager to serve as our Site Management Representative and primary liaison for all interactions with regulatory bodies, including the FDA and ISO. Reporting directly to the General Manager, you will take full ownership of the overall effectiveness of our Site Quality Program. Your mission is to ensure that every product we manufacture meets and maintains the highest regulatory standards through the rigorous application of ISO 13485 and 21 CFR 820.
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Responsibilities:
Act as the designated Management Representative for all regulatory bodies and agencies.
Establish and maintain robust Quality System procedures, instructions, and requirements in strict accordance with 21 CFR 820.
Develop a comprehensive Quality Plan that defines the practices, resources, and activities essential to our manufactured products.
Oversee the Material Review Board (MRB) process and manage the site CAPA (Corrective and Preventative Actions) system to drive continuous improvement.
Lead the Site Internal Audit program and establish robust supplier quality initiatives and audits.
Manage quality department personnel to ensure all objectives are completed timely while upholding all elements of the Site Quality Policy.
Lead formal Management Reviews with the Senior Management Team at pre-determined intervals.
Direct both receiving and production inspection processes to ensure total compliance with cGMP standards.
Working hours: 7:00 AM - 5:00 PM (Various Shifts Available)
Skills:
Six Sigma Certification: Proficiency in data-driven improvement methodologies is highly valued.
Lean Manufacturing Certification: A strong understanding of lean principles to optimize quality processes.
ISO Lead Auditor Certification: Formal certification to lead complex quality audits is a significant plus.
Education:
Bachelors
Experience:
4-7 years
Qualifications:
Regulatory Mastery: Advanced, in-depth knowledge of ISO 13485 and 21 CFR 820.
Proven Leadership: 5+ years of experience in regulatory affairs, product development, or product manufacturing in a management capacity.
Educational Foundation: A 4-year college degree (Bachelors) in Science or an equivalent technical field.
Problem Solving: Advanced communication and analytical skills to resolve complex quality issues.
Software Proficiency: Advanced skills in Microsoft Excel, Word, and Outlook for data management and reporting.
Operational Excellence: Exceptional organizational skills with the ability to work independently in a fast-paced, high-pressure environment.
Are you a quality leader who thrives on precision and regulatory excellence? This is your opportunity to lead a world-class quality program and make a tangible impact on product integrity. Apply today to join our leadership team and shape the future of our site's quality standards!
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).