Supplier Auditor, Jacksonville, Florida
Kelly Services is currently seeking a Supplier Auditor for one of our top clients in Jacksonville, Florida.
Our client is well known as one of the largest, most innovative medical device and solutions, in orthopaedics, spinal care, vision and neuroscience, in the world today.
As a Supplier Auditor placed with Kelly Services you will be responsible for:
Ensures effective supplier quality audit program. Ensures effective Regulatory Health Authority Readiness program for key critical suppliers. Accountable for the proactive identification and alerting of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. Accountable for facilitating effective and successful regulatory agency inspections.
Essential Duties and Responsibilities (Other duties may be assigned):
- Develops and executes organizational and operational policies for the supplier quality audit program.
- Ensures adherence to approved supplier audit schedule.
- Conducts supplier audits and gap assessments in support of the supplier quality audit program and regulatory health inspection readiness.
- Ensures audit reports are issued within the prescribed time frame.
- Reviews, classifies observations, and approves audit reports.
- Timely and accurately issues and maintain files associated with supplier and EM audits, re audits and corrective action responses, and performs updates in the applicable audit tracking systems.
- Monitors supplier quality audit program performance through the use of trending and metrics.
- Provides advice and guidance to auditors.
- Manages external auditors/contract resources and approves contractor invoices.
- Assists with responses to audit findings and other GMP/QMS related issues as needed.
- Supports base business projects and initiatives, as required.
- Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Assesses proposed regulations and communicates new requirements to the organization.
- Follows all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Education and/or Required Experience:
- BS in a related science or engineering field of study; and 8 or more years of related experience and/or training; or MS with 6 or more years; or Ph.D. with 4 or more years; or equivalent combination of education and experience.
- Demonstrated compliance experience in domestic and/or international quality systems.
- Experience dealing with applicable Health Authority inspections.
The position will require approximately 25% domestic travel. The ability to drive and to be comfortable with air travel are absolute requirements.
Other Skills and Abilities:
- Good written and oral English communication skills.
- Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents.
- Strong understanding in FDA CFR Parts 11, 210, 211, and 820, ICH Q7, ISO 13485 and/or other applicable regulations. Strong knowledge of quality and compliance in a regulated GxP/QMS environment.
- Ability to take in the vital points of the audit and make big picture decisions and observations.
- Ability to select, manage and direct a team for/during an audit, as applicable.
- Ability to respond to common inquiries, regulatory agencies, or members of the business community.
- Statistical skills and manufacturing process understanding.
- Ability to lead a team through a root cause analysis problem.
- Ability to effectively present information to management, public groups, and/or boards of directors.
- Engages in constructive conflict.
- High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to build partnerships both internally and externally. Ability to effectively interface with governmental and independent auditors.
- Ability to use PC's and associated Microsoft software.
- Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings are preferred.
This is a long-term open-ended opportunity, typically multi-year. This opportunity also offers an enhanced benefits package from Kelly Services which includes 401K participation, health insurance, PTO, and paid holidays.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship (F1 OPT cannot be considered for this position).
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:
- Vacation and sick pay
- Paid holidays
- 401(k) plan
- Group medical, vision, dental, life, and short-term disability insurance options
- Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
- Kelly Learning Center offers free courses and trainings
- Weekly pay
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit URL blocked - click to apply and connect with us on URL blocked - click to apply, URL blocked - click to apply and URL blocked - click to apply.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. URL blocked - click to apply
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
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. 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. URL blocked - click to apply
(American Society For Quality) Asq Certified
Six Sigma Methodology