Quality Manager (Location: St-Louis or Minneapolis)

Date: Dec 1, 2022

Location: Rolla - Missouri, US, 65559

Company: Heraeus

[title]
Quality Manager (Location: St-Louis or Minneapolis)
Affiliated with Rolla - Missouri
Permanent  
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development, and support you need to be successful now and in the future. If you want a career without limits with a market-leading, family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of around 14,800 employees brings forward new ideas and solutions that are impacting and transforming everything from healthcare and renewable energy to e-mobility, high-tech, and telecommunications.

 

ETS is a startup company that was purchased by Heraeus, the technology group in Hanau Germany that is a family-owned portfolio company. ETS is a company that is innovative, 
customer focused but more importantly patient centric. We are launching a novel wound care platform in the United States with a rich pipeline. 
 

 
 

The following challenges await you:

Act as the Quality System Management Representative
•     Ensures that processes needed for the quality management system are documented. 
•     Responsible for maintaining MasterControl, including training records
•     Report to top management on the effectiveness of the quality management system and any need for improvement
•     Ensure the promotion of awareness of applicable ISO requirements and quality management system requirements throughout the organization
•     Leads Management Reviews for the company, by evaluating and interpreting data and set performance metrics 
•     Responsible for internal and external audits (including with the FDA), manage relationships with suppliers/consultants/contract manufacturers/notified bodies to ensure company is in compliance with ISO requirements

 

Act as the ETS Quality Manger
•    Responsible and accountable to formulate policies and promote their implementation
•    Conducts gap analysis for emerging projects to meet their operational needs and rapidly fill the gaps enabling business development team
•    Creates agreement templates to rapidly enable company’s business with external partners (e.g. consultants, distributors, contract manufacturers)
•    Responsible and ensures that all regulatory requirements are met, for both domestic and international sale and distribution of the company product(s)
•    Responsible for communicating with the FDA. This entails inspection and communications with the FDA to make sure company’s policies/best practices are in compliance with FDA regulations
•    Responsible for creating/maintaining technical file for the company’s product(s) for regulatory filing
•    Ensures that the company is in compliance with legality and conformity to established domestic and international regulations 
•    Assist in training new staff on applicable SOPs and WIs. 
•    Negotiates with key suppliers to acquire cost-effective deals for the company 


Your Profile:

•    Bachelor’s degree (BS) in science, materials research, industrial engineering or related field with 15 or more years of industry experience in highly regulated manufacturing industry
•    Excellent comprehension abilities of ISO requirements, FDA regulations & other international regulations. 
•    Knowledge of various computer system (e.g. statistical software, quality management tools)
•    In depth knowledge of diverse functions (e.g. quality, regulatory, operations, relationship management with consultants/suppliers/contract manufacturers)
•    Demonstrate discretion, confidentiality, and professionalism when representing the company
•    Understanding of and ability to use continuous improvement tools for various functions 
•    Ability to drive solutions to complex issues with limited or no supervision 
•    Working knowledge of data analysis and performance metrics


Nearest Major Market: Springfield