Quality Engineer

Description

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Sanford, Maine

Full Time

The Quality Engineer provides a critical link between the Innovation team including Implementation and Support (I&S), Engineering (PD&I), 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.

Sanford, Maine

Full Time

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 (SDM) 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. Key reviewer in the Management of Change process.
Interface effectively with key business partners including Operations, Technology, Business Unit, Procurement, and Vendors to drive Company results.
Support key activities at the site by: reviewing processes and procedures including validation protocols, lead pre and post launch review meetings, submit stability samples for testing, external audit participation and other tasks as needed.
Process Validation & Control: Oversees the validation program, including C&S, conducts risk analysis, maintains and updates validation master plan, develops validation protocols for PQ, supports IQ/OQ in conjunction with the engineering team.
Lead product inspections, line trials and other Quality Key Performance Indicator (KPI's).
Conduct training sessions on topics such as GMP, quality standards, validation, etc.
Utilize quality tools such as Change Control, Failure Investigation, Control Charts, Corrective & Preventive Actions (CAPA) and Notice of Deviations, etc. to help drive continuous improvement.
Lead the Technology Transfer Quality Standard applicable to the Site for those specific site-related activities.

Required Qualifications:

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

Preferred Qualifications:

A strong background in quality systems, understanding of cGMP and 21 CFR 210 & 211, and experience in working in a regulated industry (i.e. FDA)
Working knowledge of SAP, validation software (KNEAT), InBatch or similar plant/quality related computer systems.

Recruiter Submission Template:

Full Name:

Bachelor's degree in Chemical / Mechanical Engineering, Chemistry or related science/engineering discipline?

Total years of experience in manufacturing or a quality role?

Experience with quality systems and understanding of cGMP / 21 CFR 210 & 211 (regulated industry such as FDA)?

Project management experience in a fast-paced manufacturing environment?

Working knowledge of SAP, validation software (KNEAT), InBatch, or similar plant/quality systems?

Experience with validation (IQ/OQ/PQ), risk analysis, CAPA, and Change Control?

Experience in product inspections, line trials, or quality KPI monitoring?

Why is the candidate looking to leave their current role?

Motivation / Reason for Relocation (if not local):

Motivation / Reason for interest in this position?

Contact Number:

Email ID:

LinkedIn ID:

Full Address (Street, City, State, Zip Code):

Notice period (in weeks):

Current work authorization status (US Citizen, Green Card, etc.):

Expected Salary?:

Are you ready to relocate and work at Sanford, Maine - Onsite?

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Other
Industries
IT Services and IT Consulting

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