• Act as a Quality lead to oversee day to day Manufacturing activities
• Work with internal customers and suppliers to ensure that non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed, and approved.
• Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control.
• Develop and maintains effective relationships and integrate activities with other departments and suppliers (as needed).
• Review and approve changes made to product and processes and validation/qualification protocols and reports
• Responsible for drafting and/or updating Quality Procedures for Quality Operations functions
• Initiate and develop standards and methods for inspection, testing, and evaluation as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures and training.
• Establish and maintain quality metrics.
• Identify and lead projects and initiatives to improve the quality system.
• Perform internal audits and other related duties as assigned.
• Ability to travel 10% of the time.
Other Professional Skills:
• Bachelors degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
• Minimum of 4-5 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
• Proficiency in reading and interpreting mechanical drawings and GD&T.
• Knowledge of QSR and ISO 13485.
• Knowledge of an electronic system for managing Non-Conformances/ CAPAs is preferred.
• Problem solver.
• Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, Visio and Outlook.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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