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Global Director of Quality - Interventional Urology

Company: UnitedHealth Group
Location: Minnetonka
Posted on: September 17, 2020

Job Description:

Global Director of Quality - Interventional Urology Company: Coloplast GmbH

Location: Minneapolis

Posted on: September 13, 2020

Job Description:

Career Opportunities: Global Director of Quality -Interventional Urology (48793) Req ID 48793 - Posted 30/07/2020 - United States - Minnesota, Minneapolis - Quality Assurance - Coloplast Corporation - US

Global Director of Quality - Interventional Urology

Job Function Summary:

The Global Director of Quality is responsible for leadingquality systems, quality engineering, quality assurance, supplierquality, design assurance and documentation control functions toassure compliance with applicable regulations and corporaterequirements. This position will lead a global team in both the USand France.

Major Areas of Accountability:

Develop and set strategic direction for global qualityorganization including quality systems, quality assurance, supplierquality, design assurance and documentation control.

Lead and manage global quality team by monitoring andmaintaining department goals and individual objectives.

Drive and lead the execution of the global quality managementsystem across the IU organization and ensure compliance with globalregulations.

Lead project teams that support the development of qualitydeliverables per the project plans and active monitoring ofconformance to the design assurance requirements to ensure theymeet the intended use and user needs, while assuring quality andreliability.

Lead team that manages supplier quality relationships and ensurequality standards are being met.

Lead the global internal audit program, monitoring compliance toschedules for resulting action items.

Lead CAPA and complaint handling systems, ensuring timelyreporting, adequate root cause investigations and compliance toschedule on resulting action items.

Direct the training program for assuring understanding ofquality requirements to support compliance withprocedures/instructions and applicable regulations, as well ascommunicating quality management system effectiveness to theorganization.

Lead documentation control to ensure compliance with qualitystandards and regulations.

Regularly review and maintain corporate and localprocedures/instructions to assure ongoing compliance as needed.

Lead inspections by external audits by FDA, ISO notified bodyquality audits, customers or other appropriate agencies.

Manage product reviews, product launch surveillance, andmanagement reviews while contributing to post-market surveillanceand adverse event reporting.

Review quality and process performance data against acceptancecriteria and provides strategic direction to improve performanceand compliance.

Perform complaint processing and analysis as needed.

Lead global quality function to ensure stakeholder managementand engagement with cross-functional global teams.

Identify opportunities to continuously improve qualityefficiency, costs and time factors consistent with businessobjectives.

Manage department financial budget to include capital, expense,resources, etc.

Manage performance management process for direct reports.

Bachelor’s degree in an applied technical discipline,engineering preferred

Minimum of 15 years’ quality experience in medical device andpharmaceuticals

8+ years of leadership experience is preferred

Demonstrated knowledge and application of FDA and ISO qualitysystem requirements

Ability to travel up to 20%

Excellent written and oral communication skills

Experience with quality systems

Experience in quality engineering principles including designassurance, root cause analysis, sample plans, validation, stabilitytesting, quality plans, change control, and others is required

Experience leading FDA inspections and ISO registrar audits isrequired

Pursuing an ambitious growth agenda, Coloplast develops andmarkets products and services that make life easier for people withintimate healthcare needs. Employing about 12,000 people and withproducts available in more than 143 countries, we are one of theworld´s leading medical device companies. We are constantly growingour business and always looking for new ways to move forward – weexplore, learn and look for new ways of doing things.

Coloplast is committed to a policy of Equal EmploymentOpportunity (EEO) which means we employ and promote individualsbased on their merits, regardless of race, color, religion, sex,national origin, age, disability, veteran status, pregnancy, sexualorientation, gender identity or expression, genetic information,marital status, citizenship status, status with regards to publicassistance or any other protected classification.

Keywords: Coloplast GmbH, Minneapolis , Global Director of Quality - Interventional Urology, Other , Minneapolis, Minnesota

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Keywords: UnitedHealth Group, Minnetonka , Global Director of Quality - Interventional Urology, Other , Minnetonka, Minnesota

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