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.
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).
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