Quality Assurance and Regulatory Manager

Tecomet, Inc•Manchester, NH

About The Position

The Quality & Regulatory Affairs Manager provides overall company leadership and direction to meet, create, monitor and improve the quality management systems (QMS) program, keeping the goal of the reduction of quality costs in mind while maintaining compliance within applicable FDA and ISO regulations.

Requirements

Associates Degree or ASQ CQE and/or CQA Certification may be adequate if the experience time is double
Three years manufacturing experiences
ASQ Certified Quality Auditor or equivalent
ISO/FDA Lead Assessor and/or Auditor
Strong organizational skills
Strong people and leadership skills
Diplomacy
Motivation

Nice To Haves

RAB & AMSE Certification preferred

Responsibilities

Maintain and work towards the continual improvement of the ISO-13485 program and all associated functions including management review, internal and external audits, and associated corrective and preventive actions (CAPAs).
Act as the management representative for the Tecomet-OEM Solutions Lansing Quality System with authority and responsibility for: ensuring the quality system is established, implemented and maintained in accordance with International Standard and regulatory requirements.
reporting on the performance of the quality system to Tecomet-OEM Solutions Lansing management for review and as a basis for further improvement and maintaining effectiveness of the quality system.
ensuring and promoting the awareness of regulatory and customer requirements throughout the organization.
Act as Lead Auditor to the QMS Internal Audit program
Establish and maintain quality management systems that comply with the FDA 21 CFR guidelines, mainly Part 820.
Assist in coaching and training of personnel with the QMS.
Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans
Assist in process validations as needed
Records retention/archives management
Maintain a culture where safety, quality, schedule and cost are the main focal points with a continuous improvement mentality
Project a positive and professional image of the company and of management to employees at all levels
Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures
Responsible for interviewing, providing training, counsel and evaluations, discipline and termination of employees
Promote and develop plans with Tecomet-OEM Solutions Lansing Customers to certify Tecomet-OEM Solutions Lansing preferred supplier
Develop and maintain customer relationships
Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs
Optimize manufacturing process run time by identifying and eliminating production failures
Coach and provide training for Quality Engineers, Six Sigma Green Belts and Quality Inspectors
Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans
Determine if a potential supplier has the basic systems and machine capabilities in place prior to placing an order with that supplier
Develop and administer systems that facilitate the certification of suppliers, subsequently reducing and/or eliminating Tecomet-OEM Solutions Lansing receiving inspection time and cost
Participate in the Material Review Board process
Follow-up on all internal and external corrective action responses
Internal & external audits and supplier approvals
Oversee special processes validations
Oversee gage control
Device pre-sterile packaging and sterilization requirements
Maintain a culture where safety, quality, schedule and cost are the main focal points with a continuous improvement mentality
Project a positive and professional image of the company and of management to employees at all levels
Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures
Responsible for interviewing, providing training, mentoring and evaluations, discipline and termination of employees