Job Description: Job ID: MAM000678
At Mammotome, we are committed to providing best-in-class technology to help clinicians accurately diagnose breast cancer. We provide clinicians devices spanning the breast cancer diagnostic care continuum from tissue biopsy to accurate lesion removal, never forgetting that at the heart of each breast cancer diagnosis is the patient. Through our ever-expanding product portfolio we strive every day to improve the patient's journey and achieve better outcomes. Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world.
The Supervisor, Quality Engineering provides tactical oversight of specific areas of the Quality System, and supervises the planning and direction of the individual team members in those areas. The Quality Engineering Supervisor may provide guidance to Quality Engineering areas.
Identifies and manages performance through daily, weekly, monthly metrics, with clear stakeholder communication and issues elevation.
Applies validated technical problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Serves as a potential support auditor for internal and external facing audits.
Identifies, plans and executes quality requirements resulting from internal and external changes.
Responsible for the generation and continuous improvement of metrics for all areas and levels of responsibility.
Uses the Quality Management System and Danaher Business System (DBS) in developing and executing the appropriate processes for consistent, technical, risk-based decision-making.
Supports product introductions and supply chain continuity in local markets.
Direct reports may include Quality Engineer(s), Quality Inspector(s), Quality Technician(s), Document Specialist(s), and Complaint Specialist(s).
Other duties as assigned.
Responsible and accountable for non-conformance determination.
Demonstrates responsiveness to business needs and motivation of diverse, cross-functional teams, including influencing both internal and external members to achieve positive business results.
Provides leadership to instill a collaborative and results-driven team.
Responsible for managing the activities of direct reports, for individual contributor roles.
Helps develop the organization's ability to improve through individual development and enhanced organizational capabilities.
Assists in performance management activities with the Manager, Senior Manager or Director to improve capabilities and skills using regular objective setting and review process, performing appraisals and coaching of individuals on development plans.
Assists in hiring and training of department staff and activities to ensure high performance, accountability, interdependence and teamwork.
Improves products through implementation of quality management procedures, specifications, test methods and measurement systems.
Develops new and/or improved techniques for engineering tasks.
Develops risk management plans, reports, and utilizes risk management tools such as FMEAs.
Provides guidance in the development of inspection plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and acceptance criteria and Design Validation Testing.
Minimizes customer complaints due to product quality through effective corrective action and preventative actions.
Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN).
Partners with R&D, Operations, Manufacturing, Marketing, and Regulatory to define requirements for New Product Development.
Supports the administration of project management and design control.
Bachelor's degree in a technical field (i.e., Engineering, Physical Sciences) required. Advanced degree preferred.
Professional certifications (i.e., CQE) are desirable.
Equivalent of 4 years' related work experience in Quality Engineering required.
Experience in the medical device industry (manufacturing, engineering, or technical capacity) required.
Supervisory experience strongly preferred.
Understanding of FDA regulations and ISO standards required.
Additional Success Factors
Excellent communication skills, both written and verbal
Ability to gain follower-ship, get results and hold all team members responsible for outcomes
Excellent facilitation skills. Ability to hold individuals' attention, create excitement and foster engagement.
Work closely with entire leadership team to motivate change, continuous improvement, and engagement throughout the organization
The capacity to plan, organize, & complete projects on time. Excellent project management skills and ability to balance multiple responsibilities and deadlines
Ability to lead teams and inspire change in a matrix organization
Motivated individual who is highly proactive at solving problems and obtaining results.
True love of continuous improvement, measuring results and problem solving.
Teammate who can work well across a global organization
Willingness to learn the complexities of working in a Diagnostic industry where compliance to regulation is a must.
Travel: 20% Travel including domestic and international locations.
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page
Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.