Quality Engineer

Title: Quality Engineer
Location: Sanford, ME
Job Type: FTE/Permanent
Summary:
The Quality Engineer provides a critical link between Innovation, Implementation and Support, Engineering, Category Technical Managers, Plant Operations, and Quality. The role requires attention to detail while working at an energetic pace. The Quality Engineer is active and visible in promoting plant quality performance and consumer satisfaction, supported with a strong and effective internal/external networking.
Responsibilities include:

• Provide daily support to the plant to address quality issues and continuous improvement initiatives by spending time in the production area and participating in the site Standard Daily Meeting and Internal Quality Area Meetings.
• Ensure site quality systems are configured for current and upcoming production requirements in a timely manner.
• Conduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling to ensure product quality.
• Interface effectively with business partners including Operations, Technology, Business Unit, Procurement, and Vendors to drive results.
• Support site activities by reviewing processes and procedures, including validation protocols, leading pre- and post-launch review meetings, submitting stability samples for testing, audit participation, and other tasks as needed.
• Oversee the validation program, including risk analysis, maintaining and updating the validation master plan, developing validation protocols, and supporting engineering teams.
• Lead product inspections, line trials, and other Quality Key Performance Indicator initiatives.
• Conduct training sessions on topics such as GMP, quality standards, and validation.
• Utilize quality tools such as Change Control, Failure Investigation, Control Charts, Corrective & Preventive Actions, and Notice of Deviations to drive continuous improvement.
• Lead the Technology Transfer Quality Standard activities applicable to the site.

Required Qualifications:

• Bachelor's degree in Chemical or Mechanical Engineering, Chemistry, or a related science/engineering discipline.
• Minimum of 2-3 years of experience in manufacturing, a quality role, or equivalent.
• Demonstrated project management skills, effective communication, and ability to deliver results in a fast-paced environment.

Preferred Qualifications:

• Strong background in quality systems, understanding of cGMP and relevant regulations, and experience in a regulated industry.
• Working knowledge of SAP, validation software, or similar plant/quality-related systems.