Quality Assurance Manager

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.

POSITION TITLE / LOCATION:  Quality Assurance Manager, Salisbury, MA

JOB CLASSIFICATION:  Exempt

POSITION REPORTS TO:  Director of Quality & Regulatory Assurance

POSITION OVERVIEW

The 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 Ovik Health at our Mayflower Plant in Salisbury, MA. The associate will oversee the following as well as other duties as requested: 

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

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
• Support 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 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 for location of responsibility
• Review and approve SPIs
• Develop, edit, review and approve validation protocols and reports.
• Provide employee development opportunities for direct reports
• Act as Management Representative for location of responsibility
• Own CAPA, NC, and Complaint programs for location of responsibility

2. Regulatory Affairs

• Understand current global regulations affecting medical devices with particular focus on the United States, Canada and EU.
• Develop strategies, draft responses, and/or review responses and documents intended for submission to regulatory agencies to ensure compliance with regulatory requirements and / or gain clearance for commercial sales.
• Interact with regulatory agencies as directed while documenting contact as required to gain product clearance
• Provide business-sensitive regulatory advice
• Provide regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products
• Manage projects utilizing outside consultants including seeking clearance for commercial sales in other countries
• Develop and maintain an effective regulatory affairs training program for all appropriate business associates

MINIMUM QUALIFICATIONS

• 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.

PERSONAL PROTECTIVE EQUIPMENT USED:

• Safety Eyewear
• Steel Toe Safety Shoes
• Hairnet
• Cut resistant gloves, chemical gloves, etc. as needed

PHYSICAL REQUIREMENTS                                FREQUENCY, AMOUNT, OR DESCRIPTION                                                  

1.  Standing: Ability to stand while working                                                60% of day 

2. Sitting:  Ability to sit down                                                                 40% of day 

3. Moving: Ability to move throughout plant:                                             100% of day 

4. Lifting:  Ability to lift to 25 lbs.                                                           100% of day 

5. Ascending/Descending: Ability to walk upstairs, climb to top of range  (approx. 16 ft)    50% of day 
6. Push/Pull/Reach: Ability to push/pull/reach  :  5% of day
7. Bending: Ability to pick up objects from the floor : 25% of day 
8. Visual Acuity: Visual acuity adequate to perform job duties, including reading information from printed sources and computer screens.  100% of day             
9. Cognitive: Alert. Able to make decisions, reason, and understand information.      100% of day

WORK ENVIRONMENT/SAFETY-SENSITIVE POSITION

This job operates in a manufacturing facility. This position is a safety-sensitive position and occasionally works around moving mechanical parts and powered industrial vehicles. Noise level can be medium to loud. Temperatures can vary depending upon the time of year and outside impacts. 

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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.