Kelly Services Regulatory Quality Assurance Specialist in Shirley, Massachusetts
Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a six month temp-to-hire opportunity to work as a Regulatory Quality Assurance Specialist at a prestigious Fortune 500® company working in Shirly, MA.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.
Job Title: Regulatory Quality Assurance Specialist
Pay: $56-66 per hour depending on experience
Position Summary :
The purpose of this position is to assist in the implementation, evaluation, and maintenance of a comprehensive and effective quality and regulatory program that complies with FDA regulations, ISO requirements, and other applicable regulatory bodies or standards.
Essential duties & responsibilities :
• Provide reports to the GQO Quality Manager on the status of quality programs.
• Control and oversee maintenance of documentation involved in the Quality system i.e. Device Master Records, Device History Records, CAPA system records, Complaint system records, etc.
• Provide oversight and training for site Good Documentation Practices (GDPs) and conduct document verifications for GDPs.
• Direct and when necessary, perform analytical quality assurance tests and interpret the results
• Direct and when necessary, perform internal audits of processes, facilities, and documentation to assure compliance with internal procedures, FDA regulations, ISO requirements and other regulatory agencies.
• Assist in FDA, ISO and other applicable regulatory assessment audits.
• Participate in the operation of the CAPA, PM and/or Training systems.
• Assist with writing, updating and implementing procedures and specifications detailing the aspects of an effective quality system that complies with FDA, ISO and other applicable regulations/standards.
• Assist in reviewing, maintaining and upgrading the document control system, i.e. - Master Control. Or Arena
• Assist and when necessary, direct, the efforts on process improvement projects.
• When necessary, perform label and final inspections.
• Assist in monitoring for radiation safety and maintaining radiation safety records.
Education & Special Trainings Bachelor’s degree in Engineering or Science preferred
• 5 years’ experience within a manufacturing environment with a working knowledge of quality systems
• Strong decision-making skills
• Proven leadership abilities
• Ability to work independently, plan and prioritize
• Experience with FDA Class 1 and 2 devices
• Experience with ISO 9001 and/or ISO 13485
• Experience with TGA, Health Canada, ANVISA and/or JPAL a plus Qualifications & Experience
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed here are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, surgeons, customers, and the public.
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. • Ability to apply concepts of basic algebra and geometry.
• Ability to read and understand engineering drawings.
• Must be able to investigate product problems by reviewing travelers, pick lists, and history forms to determine the chain of events based on part numbers, quantities, dates, and signatures, to avoid potential product recalls and FDA/ISO citations. This person must be able to constantly make decisions concerning the acceptability of product based on specifications, standards, and training. The position requires the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Proficient in Microsoft Office Suite. TrackWise knowledge preferred.
Physical & Mental Requirements
• While performing the duties of this job, the employee is frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear.
• Use hands to finger, handle, or feel objects, tools, or controls, reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear.
• The employee must occasionally lift and/or move up to 25 pounds.
• The noise level in the work environment is usually moderate.
• May be exposed to Hazardous materials. Employees need to consult MSDS in their work area.
• Required to wear Personal Protective Equipment to protect against exposure to Bloodborne Pathogens and chemicals.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com .
Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
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