Senior Quality Engineer

• Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
• Supports the manufacturing plant through implementation of process improvements
• Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
• Manages small projects (both new and improvement) to include cost, change management, implementation, and validation
• Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
• Performs statistical analysis to support Quality and Production
• Evaluates sampling/testing/qualification plans with respect to current quality levels and test methods
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
• Composes protocols, final reports, studies, experiments and general information reports for use by management
• Leads/coordinates validation efforts of new equipment and changes to existing equipment
• Assures compliance of manufacturing and quality control operations with respect to corporate specifications, SOPs, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations.

• Strong technical writing, investigation and communication skills required
• Experience leading cross-functional teams preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.)
• Minimum 3 years of experience in regulated manufacturing environment
• BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience.

Experience leading cross-functional teams

• Support for Parents
• Continuing Education/Professional Development
• Employee Health & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan with company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays and parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits.