Sr. Quality Engineer-Medical Device

American Medical Systems (NASDAQ: AMMD) is a global leader in providing world-class medical devices and therapies that help restore Pelvic Health.  Headquarter in Minnetonka, MN; AMS has over 1,200 Employees worldwide, selling medical technologies in more than 100 countries.

 

At AMS, our vision is to: Improve lives through innovative medical solutions. It is only through the Power of Our People that we are able to achieve this vision and provide quality-of-life solutions to so many people worldwide.  Ask AMS employees how to best describe the company and you'll hear 'fast,' 'innovative' and 'inspiring.'
Due to the company's size and organizational style, we’ll enable you to have visibility and easy access to all levels of management and your efforts will be recognized  As a globally diverse company, we value the spectrum of skills, experiences and perspectives that characterize our employees and our physician partners. We enjoy a workplace in which employees respect one another and act together.

 

 

The Sr. Quality Engineer position is primarily responsible for providing quality engineering support to existing and new product development products and projects. This person shall develop and execute quality plans and objectives for assigned product areas. The quality engineer will drive risk management and help assure products meet defined specifications and standards for safety and performance. This person will be responsible for practicing and promoting quality principles throughout the organization and help meet required regulatory compliance requirements. 

 

Essential Duties and Responsibilities:

·            Serve as quality representative and core team member on product development teams.

·            Lead risk management activities and prepares risk management reports.

·            Assure verification activities effectively prove the integrity of the design

·            Assure validation activities effectively prove the capability of the process.

·            Implement effective controls on manufactured and purchased components.

·            Provide audit support and interface with FDA and other regulatory agencies.

·            Develop and conduct internal training programs for specific quality systems.

·            Maintain current knowledge of existing products and technologies and competitive technologies.

·            Demonstrate leadership and the ability to collaborate and work in a team environment.

·            Help resolve continuation engineering and supplier quality issues.

EDUCATION

·         Minimum: Bachelor’s degree in Engineering.

 

EXPERIENCE

·         5-10 years in engineering.

·         Medical device experience and/or knowledge of FDA QSR and ISO 13485 preferred.

·         Strong background in quality tools and statistics.

·         Solid design verification and/or process validation experience.

·         Experience with electro-mechanical devices and/or chemical processes is a plus.

·         Knowledge of product standards such as UL and IEC is a plus.

·         ASQ or other quality related certifications (CQE, CQA, CRE, ISA Lead Assessor) is a plus

 

SKILLS

·         Analytical

·         Ability to collaborate across functions.

·         Quality decision making skills

·         Ability to communicate highly technical information.

·         Solid leadership and technical competencies.

 

Why AMS?

We take a comprehensive view to compensation and benefits. In fact, we are highly competitive in creating a Total Rewards program that encompasses three key areas: Opportunity, Partnership & Well-Being.  If you prefer the described work environment, and our Total Rewards philosophy is aligned with what’s important to you, please apply today. We'd love to talk with you.