Sr QA Specialist

Position Overview:

Establish and maintain Quality Systems that comply with regulations and standards. Review all records associated with the processing of human tissue products and make final decisions to release product. Exercise discretion to reduce waste and variability in processes. Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations. Ensure that all areas identified as "Principal Responsibilities" are accomplished in an efficient and professional manner.

Position Responsibilities:

• Complete all associated human tissue record reviews and make final decisions to release product based on review and discretion.
• Increase productivity and revenues by optimizing processes and work flows through experience and knowledge obtained.
• Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations.
• Working with management to formulate and using authority to implement new operating practices to improve processes.
• Using your judgement, interface with other department personnel to clarify, collaborate, and/or correct the information provided, and to solicit required information.
• Review all associated monitoring records for human tissue production departments.
• Generate Quality certificates for finished devices as required from Customer Service or Regulatory
• Maintain Quality records.
• Support and assist with other department's projects, documentation requirements, or other needs that are required of Quality Assurance.
• Develop systematic methods for completing work assignments to ensure deadlines are met and personal job commitments are accomplished.
• Perform investigations relative to the Field Assurance complaint review process and non-conformance investigations.
• Assist management with training functions as deemed necessary to ensure Quality personnel are current to updated standards, procedures, and specifications.
• Provide input to management that facilitates the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job. Initiate change requests and change orders.
• Provide Quality support to R&D and New Product Development teams.
• Present data and other important information to superiors, peers, and subordinates.
• Deploy continuous improvement programs.
• Use Lean and Six Sigma principals to reduce waste, variation, and decrease cost within Quality and other areas in the company.
• Effectively complete "other" functions that may be assigned by management.

Qualifications:

• Bachelor's Degree in the Life Sciences or other scientific field or equivalent work experience.
• Minimum 4 years' experience in Quality preferred.
• Previous experience in a regulated industry is preferred.
• ASQ or other Quality certification is preferred.
• Lean Six Sigma certification is preferred.
• Ability to analyze Quality Data.
• Must have excellent expression (both oral and written) and must be a goal-oriented team player with good collaborative skills and ability to work with internal and external contacts and customers.
• Must be opened-minded, flexible, and able to adapt easily and accept new ideas quickly.
• Must have the willingness to accept responsibility and have the ability to influence change through sound judgment and conviction.
• Maintain the ability and interest in being on the job every day as required by current attendance policies