Mfg. Process Improvement Specialist

  Sunstar Americas, Inc.                          Position Description

At Sunstar Americas, Inc., we firmly believe that our people are the foundation of our success. We foster a collaborative, innovative, and agile culture that ensures we deliver high-quality, innovative products to consumers and oral care professionals. Our team-oriented approach encourages creative thinking and nurtures a positive work environment and productive relationships. With dedication, hard work, and a shared vision, we can continue to make SAI a leader in our industry. 

Join us and become part of our global team, where together, we can achieve success and contribute to a better future.

Why Work at Sunstar? Sunstar’s mission is to enhance the health and well-being of people everywhere via its four business areas: mouth and body, health and beauty, healthy home, safety and technology.

                                                                                              MFG Process Improvement Specialist Job Code: MFGIMPSP

Position Summary:
 

This position will support the response, investigation, disposition, closure, analysis, and organization of NCRs assigned to manufacturing,  This role will work collaboratively with the various SMEs in Manufacturing, Maintenance, Quality, Materials, Purchasing, and other functions as needed, in order to resolve open NCRs.  This role will also work proactively to improve current processes and procedures to enhance manufacturing ability to produce product in compliance with all regulatory requirements and SAI standards and processes.
 

Essential Job Functions: 

•  Assess Manufacturing Capability to meet product requirements by measuring process capability of different machine centers and comparing to requirements.
• Identify areas within current SOPs for Process Improvements to streamline productivity.
• Identify opportunities for manufacturing to avoid Quality rejections via training, SOP refinement, measurement systems analysis, and Process Improvement efforts
• Learn and stay up to date on all relevant SOPs, Policies, and Work Instructions related to Manufacturing and Quality.
• Catalog, track, analyze, and help manage any backlog of NCRs.
• Respond to Quality with initial risk and disposition for NCRs. 

• Participate in meetings as required.
• Participate in seminars, web-based sessions, or occasional facilitation of classroom-based events. Continue education in areas of compliance, manufacturing processes, and FDA requirements. 

• Write up closure documentation to close NCRs.
• Track progress to the open NCR list and prioritize with input from Management and Materials.
• Help develop or refine SOPs and procedures where appropriate and directed by Manufacturing Management team.
• Collect objective evidence of actions taken to address root causes and actions documented in NCRs.
• Create and maintain a file structure on the network to organize work related to NCRs.
• Conduct and document investigations pertaining to root cause of non-conforming events.
• Other duties, as assigned.

Requirements:

•  Ability to communicate effectively and directly both verbally, written and in presentations.
• Strong Microsoft Office skills (especially Word, Excel) as well as Adobe Acrobat.
• Good proofreading, editing, and technical writing skills
• Strong problem analysis and resolution skills
• Excellent interpersonal and organizational skills
• Must be thorough and detail oriented, data-driven, and timeline focused
• Quality oriented – (the ability to maintain standards of quality against timelines/workload)
• Adaptable to change and Problem-Solving mentality – (the ability to rapidly adopt to on-going changes) – Brings solutions to the situation on a daily basis.
• Awareness of cGxP, GMP, GDP and/or ISO standards desired (specifically QSR, CFR 820, 211, Part 11 and ISO13485)

Education

•  Bachelor’s degree in a related field or two years of experience in Manufacturing, Medical Device regulated company preferred.

Knowledge/Experience

•  At least three to five years previous experience desired
• Previous experience in Quality Assurance, Inspection, or regulated organizations is preferred
• Previous experience in documentation requirements, Data Integrity requirements and database management.
• Experience with document control software (or similar platform) is preferred.
• Experience in an FDA regulated medical device manufacturing organization preferred

Skills  

• Computer Proficiency in Microsoft Word, Excel including Adobe Acrobat.
• Excellent proofreading and typing skills.
• Effective oral and written communication, training delivery and presentation skills.
• Ability to adapt to a fast-paced environment.

Abilities

• Ability to communicate, interact and work effectively with people from diverse ethnic and educational background, as well as across all levels of the organization.

What Makes Sunstar Special is:

• A business focused on health and wellness of people around the world
• High Quality Products
• Beautiful state-of-the-art facility
• Diversity and Inclusion
• Corporate Social Responsibility Program and partnership with charitable organization/
• Strong value placed on company culture
• Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits. 

• Opportunities for career growth and advancement
• Employee discount on Sunstar products
• 401K retirement plan with 2.5% employer match (Pretax and Roth options)

• 401K profit sharing contribution based on company performance.
• Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance Plans
• Competitive bonus On-site café

• On Site Fitness Center
• Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
• Holiday Lunches
• Beautifully maintained walking trails
• Hybrid Schedule (certain departments)
• Numerous employee appreciation events throughout the year.
• Recognition and Rewards Programs
• Pizza With the President
• Anniversary, Birthday and New Hire Announcements

 If you’d enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.