Director (M/F/) of Quality - Dental Business - Seefeld, Deutschland - Solventum

Solventum

Geprüftes Unternehmen

Seefeld, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Job Description:

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives.

As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best.

Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.

Because at Solventum, we never stop solving for you.

The Impact You'll Make in this Role

As the Director (M/F/*) of Quality for the Dental Solutions Business, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

Here, you will make an impact by:

Serving as the Business unit Quality Management Representative and leading the Business Quality team by providing expert-level Quality function leadership, guidance, and direction to your team on the Quality Body-of-Knowledge for end-to-end product and process quality assurance programs, procedures, and controls from new product development through post-market improvements for medical devices, drug/device combination products, drug products, and purchased finished goods_
Leading the Dental Solutions Quality team by managing the department budget, directly supervising globally located managers and higher-level professionals (including objective setting and performance management), interpreting industry trends, customer requirements, and business objectives to define guidelines, methods, and priorities, initiating and approving improvement projects to enhance product and process capabilities, and creating solutions for complex and multi-faceted problems_
Identifying and leading improvement opportunities to proactively ensure compliance to all applicable internal, domestic, and international quality regulations and competent authority requirements, including but not limited to, US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc._
Providing strategic guidance to internal organizations in the development and implementation of quality and regulatory strategies for regulated medical devices and drugs, while maintaining effective Quality metric performance by defining and executing activities to enhance product quality, reduce process variances, and resolve signals and decreases in performance_
Providing influential peer leadership as part of the Business Operating Committee to drive organizational improvements in compliance, risk management, product and process quality, quality culture, and predictive quality using industry-leading technologies, systems, and improvement tools for process control & monitoring, structured problem solving, and trend analysis with timely and effective signal resolution_

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

Bachelor's degree or higher (completed and verified prior to start) and a profound experience in Medical Device, Pharmaceutical, or Combination Product experience in a Quality function with experience in quality management demonstrating team leadership, compliance excellence, value improvement, and risk reduction_

Additional qualifications that could help you succeed even further in this role include:

ASQ Certified Quality Engineer, ASQ Certified Manager of _Quality/Organizational_ Excellence, or Certified Six Sigma Black Belt_
Skills including, but not limited to, Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device and Drug Manufacturing, Nonconforming Material Control, Customer Interaction and Support, Quality Engineering, Process Validation, Process Control & Monitoring, Risk Reduction, Continuous Process and Product Improvement, International Field Actions & Recalls, and Organizational Leadership_
Demonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and process capability and efficiency enhancement_
Strong verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, cross-functional peers, and your direct report team_
Strong leadership, decision-making, problem-solving, continuous improvement, and management skills with the demonstrated ability to create momentum and deliver results in a timely manner by _prioritizing personal workloads, as well as providing guidance, direction, and oversight to others_

Travel:
May include up to