Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

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.


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


  • 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.


  • 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.

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Principal Design Assurance Quality Engineer

Atricure, Inc.

Posted 1 week ago

VIEW JOBS 11/10/2018 12:00:00 AM 2019-02-08T00:00 AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit or follow us on Twitter @AtriCure. POSITION SUMMARY: Reporting to Director of Design Assurance, the Principal Design Assurance Quality Engineer will be part of one or more product development teams where they will responsible for contributing to the on-time development of high quality products and optimization of core design control business processes. ROLES AND RESPONSIBILITIES: * On time quality delivery of assigned product development team deliverables * Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations. * Optimize existing processes to maximize efficiencies and continue to identify, plan and execute continuous improvement activities. * Drive continuous improvements through observation, measurement and root cause analysis/resolution * Develop new processes which support speed, cost reductions and quality improvements * Provide subject matter expertise for assigned processes to users as necessary. * Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions * Provide coaching respective to investigative methods, risk mitigation techniques, Reliability analysis, design control, testing strategies and measurement system analysis (including Six Sigma, FTA, FMEA, HALT, etc) * Provide guidance for development of manufacturing test/evaluation methods and process validation * Provides investigative support/leadership for product quality issues * Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls * Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity. * Serve as technical resource for problem investigations to guide root cause analysis and corrective action development. * Provide mentorship to junior level design assurance engineers in design control and product development * Ensure commitment to functional excellence and the ability to execute positive changes BASIC QUALIFICATIONS: * Bachelor's degree in Engineering from an accredited college or university. * Minimum of 7 years of experience in an engineering role in the medical device industry * Experience in development of and linking product requirements from VOC through to design output and production controls * Experience with business process development * Experience in Reliability definition, testing and assessment * High level of knowledge/experience in statistical analysis techniques * High level of knowledge/experience in test method strategies, development and validation including GR&R * High level of knowledge/experience with risk management methodology * High level of knowledge/experience of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485 * Ability to create and manage key internal and external partnerships * Excellent written and verbal communication skills * High level of attention to detail * Familiar with product safety and standards * Ability to demonstrate proficiency in issue resolution. * Ability to multi-task and work with little direction * Ability to manage multiple priorities * Familiar with product safety standards * Ability to effectively mentor and coach others PREFERRED QUALIFICATIONS: * 10 years or more experience in an engineering role in Medical Devices * 7 or more years experience working with Product Development * Experience in processes related to Design Change Control, Design Reviews, Requirements Management * Certification in ASQ, Six Sigma/Design for Six Sigma ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement – i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %; O=Occasional, R=Regularly, N=Never): * Regularly walk, sit, and stand * Occasionally bend and push/pull * Regularly lift up to 25 pounds, occasionally lift over 25 pounds * 10% travel possibility * Position dependent upon candidate passing pre-employment physical/drug screen All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity. AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate based employees also have full access to our on sight fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: Atricure, Inc. Cincinnati OH

Quality Assurance Engineering

Expired Job