Quality Engineer-Validation

TYPICAL POSITION FUNCTIONS:

The Quality Validation Engineer is responsible for the quality control of our product design and manufacturing process control. He/she understands the Quality System Regulations and ISO standards (13485 and 21 CFR) and facilitates improvements to the quality system while providing technical quality engineering support to research and development and manufacturing. The Quality Validation Engineer serves as a Quality member on new product development (R&D) and provides technical support or leadership of quality deliverables. This position is responsible to support R&D and Operations during all product development phases and develops process qualification activities, statistically sound sampling plans and process control plans including inspection/ test method development. Additionally, this position is responsible for validation documentation of equipment, processes, methods, and software such as Master plans, IQ/OQ/PQ and Final Reports. Executes validation protocols and writes final reports. Coordinates necessary support personnel to ensure efficient and effective execution. Manages each phase of the validation as required across shifts to meet internal and external customer needs and ensure the exercise is performed and closed in a compliant manner.

PRIMARY POSITION DUTIES AND RESPONSIBILITIES:

1. Use of statistical tools to facilitate design verification test sample size and test method validations.
2. Lead Risk Analysis (FMEA-CA Design/ Process) meetings and generate final reports and actions requirements.
3. Perform analyses of failed material in order to determine the root cause. Implement appropriate corrective actions.
4. Work on new product transfers and actively participate in the qualifications and validations of product/ equipment and processes.
5. Review and approve document changes (process and design).
6. Assist R&D in test method development and conduct test method validation.
7. Develop and implement quality systems in compliance with ISO certification.
8. Review and approve receiving inspection requirements and sampling plans for components. Develop and improve QC inspection and testing method as needed.
9. Backfill quality review, QC testing, receiving inspection and product release activities as required.
10. Support the implementation of overall company validation strategy
11. Perform role to ensure all validations are in compliance with company policies and procedures
12. Assess, process and circulate protocols and final reports for review and approval
13. Execute each phase of the validation and/or solicit support to ensure adherence to the protocol requirements.
14. Report and document Protocol exceptions
15. Liaise with scheduling/planning and sales as required to ensure communication and documentation flow throughout the process.
16. Provide feedback to appropriate personnel on the validation activities and project status.
17. Actively communicate and share knowledge as required with the process engineering group.
18. Work in a safe manner in compliance with relevant policies for safety.

Comprehension of all relevant quality management system factors and documents that refer to the job category and the awareness by the individual of their relevance and importance. That includes but is not limited to, understanding of the Quality Policy, how the individuals performance contributes to meeting of the Critical Success Factors, Quality Objectives and specific job category or position related procedures.

COMPANY REQUIRED COMPETENCIES:

• Position holder will have a high school diploma or equivalency.
• Ability to speak and comprehend the English language as determined through appropriate testing and/or the interview process.
• Able to read and comprehend and to legibly write the English language as determined through appropriate testing and/or the interview process.
• Mathematics and reasoning skills as determined through applicable aptitude and achievement tests.
• A position in areas, such as the maintenance department where specific skills such as electrical knowledge are required, will require documented evidence of competency in those skills.

POSITION REQUIRED COMPETENCIES:

• Self-directed, autonomous approach to work
• Strong time and self-management skills
• Persistent approach to resolving issues
• Able to articulate persuasively while building rapport and good relationships
• Willingness to learn and adapt to varying priorities
• Bachelor of Science or related discipline
• Experience and Knowledge in Good Manufacturing Practices (GMPs) and Quality Systems and ISO-13485.
• Strong customer focus.
• Propose innovative practices to ensure processes are efficiently validated and product could be available for sale to the appropriate market.
• Experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO9001, ISO13485, etc.).
• Proficient in knowledge of variety of testing equipment (including Introns, pin gages, snap gages, micrometer, caliper, etc.).
• Proficient technical writing skills and use of documentation programs (e.g. Office Windows, Excel, Access, Power Point, etc.).
• Working knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma.
• ASQ Certified Quality Engineer Preferred.