Randstad Head of Quality Assurance and Regulatory Affairs in Jacksonville, Florida

Head of Quality Assurance and Regulatory Affairs

job details:

  • location:Jacksonville, FL

  • salary:$110,000 - $129,000 per year

  • date posted:Monday, November 26, 2018

  • experience:Experienced

  • job type:Permanent

  • industry:Manufacturing

  • reference:S_708066

  • questions:shannon.sallas@randstadusa.com904-730-9760

job description

Head of Quality Assurance and Regulatory Affairs

Jacksonville medical device company is seeking high energy candidates to oversee RA and Quality compliance for their manufacturing facility. This is a very busy position and requires working long hours.

Responsibilities:

Will be responsible for managment and direction of all Quality Assurance and Regulatory Affairs related activities at the medical device manufacturing facility. The Quality Head will have direct accountability to the company President for all Quality and Regulatory related deliverables. The Quality Head is also the Official Correspondent to the FDA for all Class I and Class II Medical Devices as both contract manufacturer and legal manufacturer, as well as Initial Importer of Medical Devices used as raw materials in the manufacturing process

Working hours: 8:00 AM - 5:00 PM

Skills:

  • Must have thorough understanding of current Good Manufacturing Practices, Quality Management Systems, U.S. FDA regulatory requirements, supplier quality management, process and equipment qualification and validation principles and in a U.S. market medical device regulated environment.

  • Working knowledge of Health Canada related regulatory requirements is a plus

  • Lead/guide all Quality Systems, Quality Engineering, and Regulatory Affairs activities - Directly or indirectly plan, write, coordinate, execute, summarize, review, IQ, PQ, OQ, validation protocols

  • Responsible for the development of quality programs and fully accountable for adherence to timelines

  • Responsible for preparation of internal monthly quality reporting

  • Manage/develop departmental budget - Recruit, hire and train direct reports

Education:

Bachelors

Experience:

Experienced

Qualifications:

  • Bachelor of Science in a Science, Technology, Engineering or other closely related discipline ASQ certified in one or more of Quality Engineer / Auditor / Manager preferred

  • 5 years of progressive management experience in medical device QA

  • ISO 13485 and 21 CFR Part 820 expertise is absolutely required

  • Proficient user of Microsoft Office applications

Please respond to this posting with a current resume or email resumes to Shannon.Sallas@randstadusa.com

Randstad is a world leader in matching great people with great companies. Our experienced agents 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, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.