Sr. Engineer, Quality Operations

• Lead NCR's, CAPA's and projects related to integration, remediation, or other items within a designated timeline to meet metric requirements through effectiveness checks
• Lead value stream monthly reviews of metrics and project status for the area
• Train and onboard team members to Quality team for operations
• Organize, review, and update applicable Quality System Documentation
• Evaluate all relevant operational data, reports, statistics, and documentation related to assigned investigation processes and projects
• Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes
• Perform root cause investigation analysis and prepare reports
• Assist in complaint/field return investigations related to manufactured product
• Lead process improvement projects (scrap reduction, defect reduction, etc.)
• Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation
• Ability to provide requirements for change control based on procedural requirements

• BA or BS in Engineering having a minimum of 4+ years related experience or 2 years related experience w/ an advanced degree or demonstrated performance and increasing responsibility within Quality roles
• Prior experience interacting with the FDA and other regulatory agencies a must
• Ability to work effectively with multi-department and multi-site teams
• Ability to manage and organize complex technical problems
• Good written and oral communication skills, excellent attention to details
• Strong team leader with management skills and focus on results
• Strong scientific analysis and troubleshooting skills
• Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes
• Must be able to sit for long periods of time
• Must have good hand to eye coordination and dexterity
• Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time

Six Sigma green belt or ASQ CQE certification highly desirable

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Medical and dental coverage
• 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 (RSP)
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits