Quality Assurance Manager

Apply now »

Date: Jan 12, 2023

Location: Salisbury, MA, US, 01952

Company: Milliken and Company

Milliken & Company is a global manufacturing leader whose focus on materials science delivers tomorrow’s breakthroughs today. From industry-leading molecules to sustainable innovations, Milliken creates products that enhance people’s lives and deliver solutions for its customers and communities. Drawing on thousands of patents and a portfolio with applications across the textile, flooring, chemical and healthcare businesses, the company harnesses a shared sense of integrity and excellence to positively impact the world for generations. Discover more about Milliken’s curious minds and inspired solutions at Milliken.com and on Facebook, Instagram, LinkedIn and Twitter.

Quality Assurance Manager 

Individual in this position will be part of a dynamic team with a proven track record of inventing, developing, and commercializing FDA registered medical devices.  In this role the individual will interact with all functional areas of Milliken Healthcare Products.  The associate will oversee the following as well as other duties as requested:

 

  1. Quality Systems
  • Develop, implement, communicate and maintain effectiveness of a quality system that is in compliance with FDA QSR and ISO 13485 standards
  • Liaison with ISO 13485 registrar to ensure activities are completed in order to maintain ISO 13485 registration
  • Manage and maintain the quality inspection and product release programs for a) incoming raw materials, b) in-process materials, c) components and d) finished goods
  • Set quality assurance objectives for the review and approval of Top Management and ensure that targets are achieved
  • Establish and maintain appropriate controls and documentation procedures
  • Participate in new product development activities to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing
  • Ensure an effective supplier quality assurance system while ensuring supplier corrective actions are timely and effective
  • Implement new inspection, measurement and testing systems for quality monitoring and improvement
  • Track and report significant quality deviations
  • Develop and maintain an effective quality systems and regulatory affairs training program for all appropriate business associates
  • Manage all audit activities including internal, external, supplier, and FDA audits.
  • Conduct Management Reviews on a regular basis
  • Review and approve SPIs
  • Develop, edit, review and approve validation protocols and reports.

 

 

Requirements:

Strong verbal and written communications skills

4+ years Quality Assurance experience including 2 + years of supervisory leadership.

ISO and FDA Quality systems knowledge.

Bachelor's Degree in Science or Management preferred.

Medical Device manufacturing desirable.

 

Milliken is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to actual or perceived race, color, creed, religion, sex or gender (including pregnancy, childbirth or related medical condition, including but not limited to lactation), sexual orientation, gender identity or gender expression (including transgender status), ancestry, national origin, citizenship, age physical or mental disability, genetic information, marital status, veteran or military status or any other characteristic protected by applicable law.