Quality Engineer
Quality Engineer
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Job Description
Job Title: Quality Engineer
Location: Sanford Maine
Duration: Fulltime
Job Description:
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.
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 (KPIs).
- 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:
- Bachelors 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) In Batch or similar plant/quality related computer systems.
Employment Type
Full Time
