QA/RA Manager

Overview

We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI.  The QA/RA Manager is a motivated, self-starter who oversees daily production and manufacturing operations to ensure manufactured products meet specifications and the operation maintains compliance with FDA and governing body regulations and standards. The QA/RA manager also promotes Keystone’s culture and values while providing leadership and direction to the Quality Department.  In addition, the QA/RA Manager must maintain high-level internal and external relationships to help facilitate smooth and timely resolution of quality issues.

A successful QA/RA Manager must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively.  This team member should have excellent interpersonal skills, great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress.

Responsibilities and Activities  

  • Lead, manage and hold the quality and regulatory team accountable.
  • Follow and ensure that all KSG employees follow all Good Manufacturing Practices and SOP’s as defined by the Company policies, practices and procedures to ensure that Company quality standards, FDA and regulatory body standards and regulations are met
  • Develop and recommend plans, programs and policies required to meet established objectives
  • Ensure processes for manufactured goods and products meet quality standards established by the Company and FDA regulations
  • Serve as designated Quality Systems Management Representative
  • Responsible for maintaining company ISO registration and compliance
  • Responsible for maintaining company FDA registration
  • Monitors upcoming changes in regulations and standards and advises how changes will impact the company
  • Act as the interface for the Company with the FDA during inspections and audits and for resolving and answering FDA comments
  • Address, investigate and resolve complaints and maintain required files and records and communicate with the FDA and regulatory bodies regarding potential problems with products in the field
  • Responsible for internal audit program and ensuring audits are completed on time
  • Owns and leads management review meetings
  • Responsible for Medical Device Reporting (MDRs)
  • Prepare and submit 510K and other required submission
  • Ensure that all records are reviewed and that standards are met prior to product release
  • Owns supplier qualifications and ensures suppliers are capable of providing meeting required standards and regulations
  • Responsible for ensuring all personnel are trained according to the KSG QMS
  • Build and maintain relationships with all department managers, external partners and customers, and vendors to make decisions regarding operational activity and strategic goals
  • Perform other duties as assigned

 
Minimum Requirements and Qualifications

  • Bachelor’s Degree in Engineering or Sciences, or equivalent work experience
  • Minimum of 7 years’ experience in a regulated manufacturing environment.
  • Familiarity with measurement equipment: calipers, rulers, micrometers, etc.
  • Familiarity with ISO Standards and GMP preferred.
  • Authorized to work in the US without sponsorship.
  • Must be able to routinely make decisions that immediately impact operations.
  • Must be able to understand and execute tasks per Standard Operating Procedures and Customer Specifications.
  • Must have the ability to operate hand tools, inspection equipment, and common office equipment.
  • Must have the ability to operate in a fast-paced environment, sometimes requiring extended work hours, including evenings and weekends as necessary, to ensure minimal interruption to production.
  • Must have excellent interpersonal communications skills to ensure core corporate values are demonstrated and promoted to all coworkers.
  • Must have excellent documentation and organizational skills.
  • Experience with sterile barrier packaging is a plus.
  • Experience working in a clean room is a plus.
  • Experience with single use disposable medical devices is a plus.
  • Experience with seal integrity and seal strength testing is a plus.
  • References must be provided upon request.
  • Basic computer skills (word processing, spreadsheets, database)

Preferred Qualifications

  • 10+ years’ experience in a regulated manufacturing environment
  • Experience in new product development / processes.
  • CQE or equivalent course work / experience desirable.
  • Proficient in understanding of Med Device manufacturing processes desirable.
  • Familiarity with ISO 13485, QSR, GDP, GMP desirable.

Benefits:

  • Excellent full-time benefits including comprehensive medical coverage, dental and vision options
  • Company paid life insurance, short term disability and long-term disability insurance
  • Retirement savings plan with company match
  • Paid vacation and holidays

attach either a .doc or .pdf copy of your resume.
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
7 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.