Quality Assurance Manager in Lehigh Acres

Lehigh Acres, Florida
Biotechnology & Pharmaceutical
Job Type
US$ 80,000 - US$ 100,000 per year
Reference Number
Giovanardi,Jackie, Spherion
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Job Description

- Develop and maintain Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, MDD, Health Canada, etc.).
- Establish and lead Quality team with the skills and abilities necessary to support the Quality Management System and the goals of the organization.
- Oversee the Quality Management System including complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration and control of nonconforming material.
- Lead Quality Engineers in the implementation of an effective product development process that complies with design control requirements.
- Establishes quality metrics monitoring, trending, response, and promotion to corrective actions as appropriate.
- Identify process improvement opportunities. Implement and develop processes and procedures that create the greatest value for the organization.
- Promote a culture of quality and continuous improvement throughout the organization.
- Partner effectively with Engineering and Manufacturing to ensure quality standards are being met.
- Ensure site readiness for external audits.
- Participate in inspections by regulatory agencies.
- Provides guidance across the organization to address compliance deficiencies.
- Duties, responsibilities and activities may change at any time with or without notice.

Working hours: Monday - Friday, 8:00AM - 5:00PM

--Bachelor's degree in Science or Engineering.
--Minimum of 5 years of professional experience and understanding of product development, manufacturing, quality control and servicing in a medical device or pharmaceutical industry.
--Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities, five or more years of management/leadership and development experience preferred.
--Working knowledge of FDA QSR, ISO, MDD, CMDCAS and/or other international quality systems requirements.
--Experience in QMS remediation and integration activities preferred.

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. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.



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