Sr. Quality Engineer

Evergen; Town of Florida (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

Evergen is seeking a professional in Alachua, FL, to oversee Quality Assurance processes across manufacturing operations. The ideal candidate has over 6 years of experience in regulated industries, a Bachelor's degree in a relevant field, and strong skills in quality management and technical writing. Certification in AATB, CTBS, or as a Lead Auditor is preferred. Candidates should be comfortable in both office and remote environments, showcasing flexibility and effective problem-solving abilities.

Qualifications

• 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
• Combination of advanced degree and experience may be considered.
• AATB or CTBS Certification preferred; Lead Auditor Certification preferred; ASQ – CQE, CBA, or CQA preferred.

Responsibilities

• Lead core team member coordinating deliverables for process improvements.
• Supervise the Quality Assurance Engineering team.
• Review quality KPI data for continuous improvement.

Skills

Excellent verbal and written communication

Technical writing

Problem solving methodologies

Microsoft Office Suite

Quality Management System software

Investigations

Statistical techniques

Education

Bachelor’s degree in relevant technical discipline

Tools

Quality Management System software

Job description

Location: Alachua, FL

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
• Leads 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
• Other duties as assigned

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
• Travel: N/A
• Physical Requirement: Move or lift objects up to 25 pounds; Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays; Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Working Environment: Onsite: Office environment with assigned workstation; Remote positions only: Home office environment with minimum distractions