- Modify and improve existing equipment. Improve manufacturing efficiency, production yields, product quality and consistency through equipment and product design.
- Finalize manufacturing methods for medical devices.
- Responsible for all aspects of Process Validations, writing and performing of IQ (Installation Qualification), OQ (Operational Qualification) and PQ's (Performance Qualification) for the implementation of new equipment and processes used in manufacturing.
- Provide assistance for prototype equipment design for producing medical devices and components.
- Responsible for processing of Engineering Change Orders (ECO's) to maintain accurate documentation of manufacturing methods.
- Analyzes and documents test results for development and pilot production runs.
- Assist with new product introduction, associated manufacturing methods and their transfer into production.
- Participate in the MRB process, being responsible for disposition of discrepant components and implementing corrective actions as required.
- Perform other related duties as required.
Required Knowledge, Skills and Abilities:
- Knowledge of Quality Assurance methods.
- Good analytical and problem solving skills.
- Experience in design development and implementation of manufacturing processes and equipment.
- Experience in handling multiple tasks in support of a high volume manufacturing environment.
- Bachelor's Degree in Engineering, or equivalent work experience.
- Minimum of three years related manufacturing experience (medical device field is preferred).
- Knowledge statistics and SPC methods preferred.
- Knowledge of FDA Code of Federal Regulations 21 and ISO standards preferred.
- SolidWorks and Minitab experience highly desired.
- Strong computer skills, including MS Office applications (Word/Excel).
Quality Requirements :
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Duties are performed in an office environment.
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