Senior Quality Assurance Engineer

Description

Position Title: Sr. Quality Assurance Engineer - Healthcare Products     

location: Dallas, Texas    

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia.  With over 7,500 employees worldwide, we manufacture on four continents and generate sales in more than 100 countries. We drive innovation and enhance performance, finding potential in the impossible.   

quick summary of the role    

We have an immediate opening for an experienced Senior Quality Assurance Engineer in our Dallas, Texas location in the Healthcare & Wellness Division.  We are searching for a talented individual who can bring a combination of technical skills, enthusiasm, problem solving capabilities, and strong communication skills. You will be responsible for developing and executing quality control strategies and procedures to ensure the highest standards of product quality. You should have knowledge of and working experience in ISO 13485, 21 CFR Part 211, 820, and 11.  experience with automation and software testing, and a strong understanding of engineering principles. You should also have excellent communication skills and the ability to work effectively in a team environment.    

Job Description    

• Leads Quality improvement efforts by identifying quality bottlenecks and corrective measures to eliminate this.
• Capable of writing CAPAs,
• methods to captures quality metric data and performs appropriate analysis to effectively monitor and enhance the Quality Management System (QMS).
• Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials. by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.
• Assures new or modified processes or documents conform to quality standards and establishes compliance with the quality system.
• Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by meeting business needs.
• Serve on process / product improvement teams promoting and assuring quality in product development projects.
• Works with Production Management to reduce and controls Manufacturing process defects (scrap, nonconforming material, and customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Responsible for creating risk analyses and FMEAs.
• Works with Process Engineer to develops and implements Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.

• Develop and execute quality control strategies and procedures to ensure the highest standards of product quality.
• Evaluate product performance, identify areas of improvement, and recommend solutions to ensure product quality.
• Analyze quality control data and develop reports to identify trends and recommend corrective actions.
• Coordinate and collaborate with internal departments to resolve quality issues.
• Capable of interfacing with Regulatory, Notified Body or Client Audits and assessing possible findings and responding to these in a timely manner.
• Ensure compliance with applicable industry standards and regulations.
• Stay up to date with best practices and industry developments related to quality assurance.
• Train and mentor junior quality assurance engineers.

Required Qualifications   

• Bachelor’s Degree in related Technical Field (Science or Engineering) OR an equivalent combination of education and work experience   

• Minimum 8 years previous Quality Assurance experience, auditing experience  and demonstrated knowledge using quality tools/methodologies.   

• Minimum 8 years   

Preferred Qualifications   

• Experience working in a broader enterprise/cross-division business unit model preferred.   

• Ability to leverage and/or engage others to accomplish projects.   

• Excellent communication skills, both oral and written, and the ability to effectively communicate at multiple levels in the organization.   

• Multitasks, prioritizes and meets deadlines in timely manner.  

Strong problem solving skills, very organized, attention to detail and can perform under pressure.
   

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