Principal Quality Engineer
|Employment Type:||Full Time|
|Department:||Quality & Regulatory|
Executes Quality Engineering and Reliability Engineering function for Devicor Medical Products, Inc. in Cincinnati, OH. Participates in planning, execution, and implementation activities for New Product Development and Sustaining Engineering projects and is a key member of the Quality and Regulatory Affairs technical team. Responsible for compliance programs as it relates to new and existing products.
- Improves products through implementation of quality management specifications, procedures, test methods, and measurement systems.
- Develops new and/or improved techniques for engineering tasks.
- Provides product reliability assessments and create reliability test plans.
- Develops risk management plans, reports, and utilize risk management tools such as FMEAs.
- Supports the administration of project management and design control.
- Minimizes customer complaints due to product quality through effective corrective action systems.
- 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 and changes to existing products.
- Validates product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.
- Initiates and directs corrective actions to problems relating to product or process quality.
- Communicates essential Management Review data to senior leadership such as complaint trending and analysis.
- Provides QE support for contract manufacturing operations for Devicor Medical Products.
- Other duties as assigned.
General Skills/Competencies/Specialized Knowledge
Strong analytical Skills
Strong statistics knowledge as it relates to New Product Development
Communication Skills - Communicates effectively at all levels of the organization, both written and verbal. Strong interpersonal skills.
Teamwork - Works collaboratively and cooperatively with many teams cross-functionally. Energetic and willingness to work closely with all team members to achieve success.
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.
Adaptability - Embraces and adapts to change. Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances. Ability to identify urgent issues and respond accordingly. Accuracy and attention to detail.
Global/Business Perspective - Shows understanding of issues relevant to organization. Keeps up to date with current practices and trends. Has and uses cross-functional knowledge.
Must be able to travel up to 25% 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
- Minimum of 10 years of experience with Quality Engineering in the food, drug, or device industry required
- History of success in making change and achieving objectives required
- Successful track record working in a matrix/collaborative environment required
BA/BS degree required, preferably in a technical field relating to engineering or science
Professional certifications (CQE & CRE) preferred
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