Overview:
We are seeking a highly skilled Senior Quality Engineer to join our team. The ideal candidate will be responsible for ensuring that our products meet the highest quality standards and comply with all relevant regulations.
Duties:
- Develop and implement quality assurance policies and procedures
- Conduct quality audits to identify areas for improvement
- Manufacturing Process Improvements
- Update pFMEA
- Oversee QA/QC processes to ensure product integrity
- Collaborate with cross-functional teams to drive quality initiatives
- Lead quality control activities and provide guidance to junior staff
- Manage projects related to quality improvement
- Analyze data to identify trends and areas for enhancement
- Conduct thorough quality inspections
Qualifications:
- Bachelor's degree in Engineering or related field; Master's degree preferred
- Expertise in Process Validation & Computer Software Validation
- Proven experience in quality engineering, preferably in a regulated industry
- In-depth knowledge of FDA regulations, CGMP, and HACCP standards
- Strong understanding of quality control methodologies and tools
- Ability to analyze complex data sets and drive data-based decisions
- Excellent communication skills and ability to work collaboratively
Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records.
Job Type: Full-time
Pay: $50.00 - $65.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Referral program
- Vision insurance
Schedule:
Education:
Experience:
- Quality Engineering: 5 years (Preferred)
- Process Validation: 2 years (Preferred)
Ability to Relocate:
- Billerica, MA: Relocate before starting work (Required)
Work Location: In person