Design Quality Assurance Engineer
hace 3 días
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Design Quality Assurance Engineer
The primary purpose of this position is to support new product development activities to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and the company’s Policies & Procedures.
Accountabilities and Responsibilities
- Adheres to Integer’s Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
- Assists in the preparation of related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports.
- Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development.
- Participates in the preparation of Quality Plans.
- Management of ECOs as EGOM.
- Management of dummies.
- Supports sourced item qualification activities and supports supplier risk management initiatives.
- Maintains strong relationships with internal and external customers to ensure on time project deliverables.
- Implementation of corporate procedures.
- Performs other functions as required.
Education and Experience
- Minimum Education: Bachelor´s degree in engineering or technical field.
Knowledge and Skills
- Special Skills
- Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
- Excellent communication and relationship building skills.
- Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem-solving skills.
- Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
- Proficient use of a PC, office software (MS Office Suite)
- Specialized Knowledge
- Advanced English level.
- Knowledge of current FDA, ISO, MDD, and other pertinent Design Control requirement.
- Comprehension of development/engineering principles, sufficient to allow participation in new product development or other projects.
U.S. Applicants: EOE/AA Disability/Veteran
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