Quality Control Manager I

Position Summary

Leads a team of Quality Assurance professionals and provides quality process support in accordance with the Quality Management System (QMS). This is a key role responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local facility. The role involves hands-on work in quality and compliance activities around QMS processes as well as people leadership.

What we can offer you

Our Total Rewards Program goes far beyond base compensation by providing a more fulfilling work experience and offering a competitive benefits package.  

• Health, Dental, and Vision insurance available on your 1st day of employment 
• Generous retirement saving plan 
• Self-managed time off  
• Career progression and development plans 
• Company wellness, rewards and recognition, and employee discount programs 

Core Responsibilities and Tasks

• Creates a Quality culture by driving compliance activities around a specific product, facility or vendor. This includes being responsible for the total quality management system for the facility and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents Evoqua to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, reporting and operating mechanisms.
• People leader with direct reports. Has ability to attract and retain talent while coaching them to grow and further build their own expertise and ability to influence. Manages a small team of quality engineers and quality technicians testing products. Responsible for creating a high-performing team with a culture of quality and trust that enables this culture.
• Established expertise within all Medical Device QMS processes.
• Has ability to organize, drive rigorous compliance of and lead a successful QMS processes at a medical device production and distribution facility including audits and management reviews.
• Communicates complex messages and negotiates mainly internally with others to adopt a different point of view.
• Uses high level of judgment to make decisions and handle complex tasks or problems that impact the site’s compliance. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations.  
• Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
   

Position Requirements

FORMAL EDUCATION: 

• Required: BS Degree in engineering or quality management accredited college or university 

 
KNOWLEDGE & EXPERIENCE:

• Minimum 7 years’ experience in Quality Assurance / Regulatory Affairs and 5 years of management experience. Ability to effectively communicate technical information in English (both written and oral).

2.    ADDITIONAL DIMENSIONS:

• Strong leadership and communication skills. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, production & process controls, Corrective & Preventive Action (CAPA), complaints & risk management.
• Requires flexibility to shift from office environment to supervision of production team members and investigations on the shop floor.
• Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance. 
• Experience leading and implementing change. Experience performing internal audits and participating in external audits.
• Requires analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures)
• Direct supervision of quality team

TECHNICAL/SKILL REQUIREMENTS:

Required:     

•  eQMS applications
• Microsoft Office programs 

Preferred:    

• Exposure to or experience with regulatory requirements in North America
• Medical Device background 
• Experience with Lean Management, scorecards and indicator management
   

Additional Details

Travel- 10% 

LI-NH1