Supplier Quality and eQMS Specialist

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 and  LinkedIn.

POSITION TITLE

Supplier Quality and eQMS Specialist, Mayflower Plant

POSITION REPORTS TO:

Quality Assurance Manager, Mayflower Plant

LOCATION:

This job is on-site at our Mayflower Plant in Salisbury, MA.  This is not a remote position.

POSITION OVERVIEW

Job Description: 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. The individual assists with the daily management and maintenance of a medical device quality system.  The individual also assists with the review of all Supplier Quality for OVIK Health.  The associate will perform or assist in the following key responsibilities and key duties as well as other duties as requested.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES FOR SUPPLIER QUALITY

• Manages supplier quality program to ensure risk evaluations, audits, quality agreements, and annual performance reviews are being completed as defined within our procedures across OVIK Health: RMC, Hatch, Salisbury, and Portsmouth
• Acts as the primary Quality Point of Contact for critical suppliers.
• Manages supplier deviations and approvals. 
• Manages and executes batch release activities for contract manufacturers
• Manages supplier corrective action requests
• Supports sterility program (quarterly dose audits, annual review, dose mapping, etc.) across OVIK Health
• Supports maintaining the effectiveness of our division’s quality management system 
• Supports other quality and regulatory tasks as needed
• Participates in Management Review to ensure supplier quality is managed effectively to meet quality objectives
• Conducts quality release testing as needed across the division
• Any other responsibilities as assigned

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES FOR MEDICAL DEVICE QUALITY SYSTEM

• Assist with the implementation and maintenance of a Quality System based on ISO 13485 and FDA Quality System Regulation (QSR)
• Document Control – Responsible for control of all documentation required for the Quality System for Salisbury, Portsmouth and Division wide documents
• Acts as subject matter expert for eQMS (Electronic Quality Management System), Greenlight Guru
• Monitor status of Corrective and Preventive Actions (CAPAs), Customer Feedback (CF’s), and Nonconformances (NC’s) to ensure the program is effective
• Identify quality issues as they arise and communicate to management
• Maintain quality system procedures and ensure all necessary documents are properly controlled
• Assist in development and maintenance of an effective quality system training program for all appropriate quality processes 
• Assist in implementation of new inspection, measurement and testing systems for quality monitoring and improvement
• Track and report significant quality deviations
• Conduct Batch Record (Device History Record/DHR) reviews (including sterile)
• Assist with quality inspection and product release programs throughout all stages of production
• Participate in new product development activities to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing
• Participate in audit activities including internal, external, supplier, and FDA audits

REQUIREMENTS & QUALIFICATIONS

• High school diploma
• Strong verbal and written communication skills
• Excellent Microsoft Word/Excel/Outlook/PowerPoint skills
• Ability to work in a fast-paced work environment
• Self-starting and ability to work within a team environment
• Prefer ISO 13485 and FDA Quality systems knowledge
• Prefer Medical Device manufacturing experience
• Prefer English and Spanish language proficiency (spoken and written)
• Willing to travel to Headquarters in Spartanburg SC, to OVIK Health manufacturing locations, and to OVIK Health’s Supplier locations as needed

PHYSICAL REQUIREMENTS

• Standing:  Ability to stand while working                                                                    50% of day
• Sitting:  Ability to sit down                                                                                           50% of day
• Moving:  Ability to move through the plant                                                                 90% of day
• Lifting:  Ability to lift up to 25 lbs                                                                                 15% of day
• Ascending/Decending:  Ability to walk upstairs, climb to top of range (approx. 16 ft)

10% of day

• Push/Pull/Reach:  Ability to push/pull fabric rolls, A-frames (approx. 1500 lbs)       10% of day
• Bending:  Ability to pick up objects from the floor                                                      25% of day
• Visual Acuity:  Visual acuity adequate to perform job duties, including reading information from printed sources and computer screens                                                                   100% of day
• Cognitive:  Alert.  Able to make decisions, reason, and understand information.          100% of day
• Pulmonary:  Ability to work in cotton dust environment.  Meet cotton pulmonary function requirements.                                                                                                                   100% of day
• Latex:  Ability to work in latex manufacturing environment.                                       100% of day

WORK ENVIRONMENT / SAFETY-SENSITIVE POSITION

This job operates in a manufacturing facility.  This position is a safety-sensitive position and regularly works around moving mechanical parts and powered industrial vehicles.

PAY TRANSPARENCY

The hourly rate range for this position is $24.67 - $43.16; the exact hourly rate depends on several factors such as experience, skills, education and budget.

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.

To request a reasonable accommodation to complete a job application, pre-employment testing, a job interview, or to otherwise participate in the hiring process, please contact TalentAcquisition@milliken.com.