Senior Quality Engineer

Responsibilities

• Serves as a lead core team member of cross-functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility
• Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives
• Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams
• Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus
• Led and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives
• Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives

Requirements

• Education: Bachelor’s degree in relevant technical discipline
• Experience: 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience. Combination of advanced degree and experience may be considered.
• Certification: AATB or CTBS Certification, preferred Lead Auditor Certification, preferred ASQ – CQE, CBA, or CQA, preferred
• Skills: Excellent verbal and written communication, Technical writing, Problem solving methodologies, Microsoft Office Suite, Quality Management System software, Investigations, Statistical techniques

Qualifications

• No travel required

Benefits

• Paid Time Off (PTO)
• 401(k) with up to a 6% company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• Paid parental leave and much more!

Pay

Annual Bonus Opportunity up to $10,000.00

Schedule

Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions

Benefits Package

• Comprehensive benefits package including:
• Paid Time Off (PTO)
• 401(k) with up to a 6% company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• Paid parental leave and much more!