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165404,  Quality Auditor - MI -

Category: MAN
Job Title: Quality Auditor - MI
Region: MI-Michigan
City: Caledonia
State: MI
Rate: $25 to $33.09 DOE
Duration: 3 months
Description: Chipton Ross is seeking a Quality Auditor in Caledonia, MI.

JOB DESCRIPTION:
o Perform periodic documented examination and verification of activities, records and processes of quality system to determine the effectiveness and dependability of the system according to an approved audit schedule

RESPONSIBILITIES:
o Prepares audit materials for different sections of the regulations and standards that Aspen Surgical must comply with, ensuring all areas of the regulations are audited annually
o Prepares audit plans, checklists and audit reports
o Works with department managers to schedule and execute audits according to an approved audit schedule
o Formally documents audit findings utilizing good documentation practices and objective evidence
o Assures audit reports are distributed to management having responsibility for the area being audited
o Works with the auditee to resolve compliance issues, provide recommendation, communication on status of action resolution
o Brings issues to management which require attention, tracking, corrective actions or if agreement on resolution cannot be reached.
o Performs necessary follow-up including communication with auditee(s) on status of action resolution
o Performs re-audits on areas requiring follow-up and/or effectiveness verification
o Maintains audit files generated from each audit
o Provides internal communication regarding compliance issues and applicable regulation changes
o Aids in the creation of gap analysis to any new or changed regulations
o Makes recommendations and changes to the Aspen Surgical procedures and processes to address regulation and standards changes
o Supports supplier quality audit program

REQUIREMENTS:
o 3-5 years of experience responsible for Regulatory Audits preferred
o 3-5 years of experience in a regulated industry experience that includes FDA, ISO, Canadian & Japanese requirements preferred
o ASQ certification a plus
o Communication - displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels
o Ability for minimal travel via car or plane for domestic travel
o Flexibility and Adaptability - make effective decisions and maintain effectiveness under changing circumstances and priorities
o Teamwork, communication, positive attitude required to support the manufacturing environment
o Problem Solving - able to perform root cause analysis and implement effective corrective actions
o Project Management - able to effectively manage and complete multiple projects simultaneously
o Computer Skills - Excellent computer skills including but not limited to Microsoft Office Suite

QUALITY AND REGULATORY REQUIREMENTS:

o Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
o Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations

EDUCATION:
o Bachelor's degree in a science field is preferred

SCHEDULE:
o Full-Time


Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Chipton-Ross is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Contact:
Emmanuel Morgan at emorgan@chiptonross.com
CHIPTON-ROSS, INC.
343 Main Street
El Segundo, CA 90245

Phone: (310) 414-7800 x239 or (800) 927-9318 x239


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