Senior Quality Engineer

Responsibilities:

Will be responsible for managing quality related problem solving and continuous improvements opportunities.

Lead / Support Change Control to manage business needs and continuous improvement activities.

Provide guidance and approvals of applicable validations and change control documentation.

Manage NC/CAPA through identification and development of corrective action plans through closure.

Evaluate data using statistical tools.

Provide technical support to production in defining and resolving problems.

Ensure compliance and plant quality system elements.

Lead and Participate in Risk Analysis activities.

Participation in audits.

Identifying opportunities for continuous improvement.

Review and approval of work instructions.

Ownership of the process control plan and its implementation.

Other projects as required.

Requirements:

Bachelor's degree in science or related field required.

Master's degree preferred. Equivalent combinations of education, training, and relevant work experience may be considered in lieu of a Bachelor's degree.

Minimum of 5-7 years of experience in Quality Engineering or related field within a regulated industry, preferably medical devices.

Knowledge of ISO 13485, FDA 21CFR820 requirements in addition to system development and management in medical device industry.

Strong statistical analysis, knowledge of sampling plans and root cause investigative skills.

Six Sigma Black or Green Belt certification preferred.

Computer experience with MS Office Suite and database type software.

Demonstrated project management and leadership skills.

Strong written, oral and interpersonal skills.

Ability to work in team environment.

Ability to manage varied workload and prioritize effectively.

Exhibit attention to detail.

Capacity for innovation and ability to work on own initiative.