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Quality Assurance Engineering

Expired Job

Danaher Cincinnati , OH 45201

Posted 3 months ago

Job Description: Job ID: MAM000553

About Us

In December 2014, Devicor Medical Products, Inc. was acquired by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in anatomic pathology solutions and automation, striving to advance cancer diagnostics to improve patients' lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer.

Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. Mammotome remains committed to its heritage of advancing technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast care information for patients.

Devicor Medical Products, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.

Description

The Quality Engineer executes Quality Engineering function for Devicor Medical Products, Inc. and participates in planning, execution and implementation activities for new (R&D), existing (Sustaining), and contract manufactured (CMO) product.

  • Improves products through implementation of quality management policies, 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.

  • Responsible for review and approval of drawings, calculations, and specifications.

  • Provides support 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.

  • Supports the execution of the Purchased Part Approval Process (PPAP).

  • Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

  • Provides trending analysis on quality issues and performance metrics.

  • Coordinates and participates in elements of investigations regarding customer complaints.

  • 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).

  • Works with Manufacturing, Marketing, Regulatory, and R&D functions to define requirements for new product development.

  • Supports the validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.

  • Supports the administration of project management and design control.

  • Other duties as assigned.

  • Corrective and Preventive Action Coordinator / Quality Engineer

  • Provide guidance and oversight of the CAPA process to include assisting with investigation for non-conformities relating to product, processes, and the quality management system.

  • Develop and maintain a process that provides a framework for root cause analysis and effective and sustainable countermeasures.

  • Issue and maintain the log of CAPA tracking numbers, ensure the completeness of the CAPA file, and train new employees on the CAPA process requirements.

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.

Job Requirements

Qualifications

  • Minimum of 2 years of experience with Quality Engineering or Quality Assurance, preferably in the food, drug, or medical device industry required (for Quality Engineering/Quality Assurance Requirements).

  • Education

  • Bachelor's Degree in a technical field (i.e., Engineering or Technical Sciences) required.

  • Professional certifications (i.e., CQE) preferred.

General Skills/Competencies/Specialized Knowledge

  • Statistical and Analytical Skills Strong technical and analytical skills. Identifies and understands relevant trends, opportunities, needs and market direction within the medical device industry. Proven ability to analyze and interpret data, to provide guidance, data driven decisions and recommendations.

  • Communication Communicates effectively at all levels of the organization. Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others. Communicates and listens effectively in order to develop and maintain key business relationships.

  • Interpersonal Skills Ability to work with co-workers and customers, both internal and external, of all levels. Ability to professionally interact and build constructive and effective relationships with all levels and functions within the Company. Ability to effectively interface with others on behalf of the organization. Influences key business partners and customers to achieve mutually beneficial results.

  • Initiative Ability to work well independently and exercise appropriate judgment under general direction. Ability to prioritize workload, goals and tasks consistent with the department and corporate objectives. Ability to take direction from multiple sources and manage conflicting priorities in an effective and efficient manner. Ability to multi-task, completing concurrent projects within given time frames and managing interruptions and change requests. Takes initiative to establish new processes and methods to support a variety of coordination activities.

  • Problem Solving Uses rigorous logic to solve problems. Probes all sources for answers. Looks beyond the obvious. Enjoys solving tactical and process problems. Applies appropriate theory and principles, expert judgment, and cross-functional expertise to address a broad range of complex problems.

  • Decision Making Makes timely, sound decisions based on analysis, wisdom, experience and judgment. Utilizes a high degree of creativity and latitude. Relies on extensive experience and good judgment to ensure that expectations are met and that business objectives are achieved. Uses skills of observation, interpretation, analysis, inference, evaluation, and explanation to support a decision.

  • Adaptability Embraces and adapts to change and demonstrates a willingness to learn. Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances. Ability to respond quickly to change, and to prioritize actions to meet customer needs.

  • Trust and Integrity Interacts with others in a way that gives them confidence in one's intentions and those of the organization. Accepts responsibility for one's own decisions and actions. Demonstrates honesty. Keeps commitments. Behaves in a consistent manner and is open, honest and trustworthy.

  • Collaboration and Teamwork Works collaboratively and cooperatively with many teams cross-functionally. Ability to work well with other people to solve problems and to find the best solution. Energetic and willingness to work closely with all team members to achieve success.

  • Customer Orientation Demonstrates a keen understanding of various customers' (internal or external) needs and utilizes a variety of Devicor resources to provide solutions and a compelling value proposition.

  • Business Acumen Strong grasp of business concepts and related issues. Shows understanding of issues relevant to organization. Keeps up to date with current practices and trends. Has and uses cross-functional knowledge.

  • Project Management Ability to plan, organize and manage resources to bring about the successful completion of specific project goals and objectives.

  • Computer Skills Proficient computer system based tools including Microsoft Office applications, presentation, e-mail, web browsers and spreadsheet software.

Travel

  • Must be able to travel up to 10% of the time; both domestic and international travel is required.

  • Typical work-related travel assignments range 3-5 days, and as such overnight, out-of-town stays are required.

Work Environment And Physical Demands

  • Typical office environment accommodations will be evaluated where needed.

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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.


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Quality Assurance Engineering

Expired Job

Danaher