Quality Manager

Quality Manager ? Summary
On behalf of our client Kelly Engineering is searching for a Quality Manager experienced and knowledgeable of ISO 9001 and ISO 13485 medical Device Manufacturing standards.
Utilizes data to drive corrective, preventive, and continuous improvement actions.
Champions the use of the Quality System to ensure compliance with regulatory requirements to ensure the continuous manufacture of products consistent with established customer and internal requirements.
Follows business and safety guidelines.
Assists, as needed, in other areas of business/manufacturing.
Manages direct reports to support their efforts with their quality functions.
Job Details
Drive Corrective, Preventive and Continuous Improvement Actions, including acting as
Customer Representative.
o Act as direct contact for customer quality related issues; coordinate course of action for
alleviating and resolving
concerns and providing timely responses.
o Ensure Management reviews are conducted to provide for systems review.
o Manage Internal Audit Program.
o Identify corrective/preventive actions for continuous improvement (effectively
implemented and closed in a
timely manner) and quality improvement as needed for Production and Business Unit
o Ensure completion of necessary paperwork such as CAPACIAs, Alerts, and other relevant
o Ensure Root Cause Analyses are conducted to establish reasons and solutions for
Quality matters.
Maintain the ISO 13485 Quality Management System, including providing training support.
Effectively interact with Production and Development teams to
o Maintain product supply.
o Help introduce new products, including quality planning.
o Oversee sampling inspection and testing of received parts, components, and materials
to determine conformance to standards and customer requirements.
o Use logic, knowledge, and skills to oversee QA/QC activities throughout manufacturing
location and of direct Reports.
o Use charts/data for scheduled meetings and conduct/participate in meetings as
o Supervise direct reports.
Work with the Quality team that is able to handle the day to day production activities with
minimal direct supervision and guidance.
Offer input for areas for improvement in products, processes and procedures.
Support Sales/Engineering/Management with special projects.
Performs other duties as assigned.
Quality Manager ? Skills and Experience Requirements
4-year quality, technical, or related degree and 2 years medical device experience
Certification to internal auditing preferred
5+ years of experience managing/supervising direct reports.
Experience in medical device manufacturing environment (or food and/or aerospace production).
Knowledge/experience with ISO 13485 Quality Standard and CFR 820 regulatory requirements.
Experience with Plastics/Injection Molding manufacturing
Ability to apply advanced mathematical concepts and theory such as geometry, statistics, algebra, calculus, and differential equations to address engineering issues.
Excellent verbal and nonverbal communication skills.
Attention to detail, dedication, strong work ethic, good communication skills, time management abilities, team player, flexibility/adaptability, and strong interpersonal skills are needed.

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