- Professional
- Bureau à Gainesville
The QA Validation Engineer provides cross-functional support in validation and verification (V&V) development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of Quality Assurance and V&V.
Key Responsibilities
- Provides verification and validation expertise through IQ, OQ, and PQ protocol development and execution utilizing approved product and process validation SOP.
- Develop validation and verification plans and protocols for new product manufacturing (internally and externally) and related inspections.
- Participate in the validation of corporate software packages ensuring adherence to industry requirements.
- Executes, as directed, activities related to the compliance of the sterility assurance program (e.g. Biocompatibility/Endotoxin testing, environmental monitoring, and quarterly dose audits).
- Executes, as directed, activities related to the Exactech Analytical Laboratory (e.g. Analytical testing and reporting, equipment qualification, equipment preventive maintenance and equipment calibration).
- Prepare documentation and execute V&V activities utilizing a risk-based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations.
- Coordinate personnel training, protocol and process documentation/record retrieval, as necessary, supporting timely execution and closure of all corporate V&V activities.
- Maintain corporate validation process auditing program ensuring timely completion of auditing activities.
- Work closely with QA management to maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings.
- Participates in the identification, maintenance, development and enhancement of corporate systems, processes and standards.
- Assists in identifying, analyzing and correcting internal and external manufacturing deviations, QE MRB related issues and/or anomalies related to V&V activities ensuring optimization of production processes.
- Successfully contributes to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation.
- Participates in company-wide QE and validation related Corrective and Preventive Actions that may result from internal/external non-conformances, recalls and/or field actions.
- Participates in third party, customer and regulatory audits as required.
- Participates in E&D design control processes related to design inputs and defines product/process inspection requirements for all current and new products.
- Analyzes, justifies, and recommends purchase of in house or vendor supplied inspection equipment.
- Responsible for QE related DCR product and process change review and approval.
- Know and apply the Quality System and any appropriate Federal and International standards.
- Assist and support other employees, teams, and sales personnel and performs other tasks as necessary.
Skills Knowledge and Expertise
Education:
- Bachelor’s Degree from an accredited institution required.
Experience:
- Minimum 3 years experience in the medical device industry
- Advanced level of technical software proficiency
- Excellent Quality System knowledge required
- Strong time management and project management skills are necessary.
- Experience writing IQ/OQ/PQ V&V protocols
- Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations
- General understanding of sterilization and related analytical testing is a plus
- Must be able to work independently and in a team environment
Functional/Technical Knowledge, Skills and Abilities Required:
- Statistical expertise in areas such as process capability, process assurance and sampling
- Understanding of US and International Medical Device Regulations and Standards
- Familiarity with ISO 13485 and ISO 14971
- Expertise in Microsoft Office products
- Ability to work effectively in a team environment
- ASQ Certifications preferred
- Advanced level of technical software proficiency
- Working knowledge of statistical analysis and sampling plans
- Excellent communication (written and verbal) skills Excellent organization skills
