US: Senior Quality Validation Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Senior Quality Validation Engineer
Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports.
Executes activities related to the compliance of the sterility assurance program (e.g. Biocompatibility/Endotoxin testing and quarterly dose audits).
Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies.
Leads or participates in the validation of corporate software packages ensuring adherence to industry requirements.
Bachelorís Degree from an accredited institution required; Masterís Degree preferred
∑ Minimum 7 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
∑ Expertise in Microsoft Office products
∑ 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.
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI