Quality Engineering Technician, Global Equipment Management (GEM) (On-site)
Full Time
Acton, MA
Posted
Job description
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
Job Title: Quality Engineering Technician, Global Equipment Management (GEM)
FLSA Status: Exempt
FLSA Status: Exempt
Position Overview:
Supports the Enterprise Asset Management System for site Quality. Actively liaisons with Manufacturing, Quality Systems, Lifecycle Engineering, Research and Development and IT organizations to provide feedback, analysis, and trends from the work execution system to drive product/process improvement initiatives. Supports Regulatory activities such as WO timeliness/inspections/training and ensures current system data is in a compliant state.
Responsibilities:
Supports the Enterprise Asset Management System for site Quality. Actively liaisons with Manufacturing, Quality Systems, Lifecycle Engineering, Research and Development and IT organizations to provide feedback, analysis, and trends from the work execution system to drive product/process improvement initiatives. Supports Regulatory activities such as WO timeliness/inspections/training and ensures current system data is in a compliant state.
Responsibilities:
- Support root cause investigations for all Severity A and Severity B defects within the Master Control system.
- Track, trend and analyze maintenance system data and provide routine feedback to Manufacturing, Quality, and Lifecycle Engineering and Research and Development groups for all Insulet sites.
- Drive continuous improvement into the investigational process to yield more efficient and robust processes.
- Enhance quality system processes (QSP, QWI, P, CP, and PM) as it pertains to management of assigned deliverables to ensure compliance.
- Conduct trainings and certification assessments for Enterprise Asset System users.
- Generate monthly and quarterly data analysis reports for management visibility.
- Assist or leads CAPA evaluation and closure as related to the EAM System.
- Support product release initiatives and tasks as needed.
- Support site for external supplier and internal audits.
- Support site for external audits (i.e., BSI, FDA, customer).
- Maintains accuracy of supplier calibration reports.
- Verify Calibration and Preventative Maintenance execution per defined schedule.
- Support Calibration execution by Vendors (Planning/Escorting/WO Completion).
- Performs other duties as required.
Education and Experience:
Minimum Requirements:
Minimum Requirements:
- BA or higher with at least 2 years or equivalent experience in a life sciences technical department or prior quality or military.
Preferred Skills and Competencies:
- Should have a technical background in R&D, Technical Services or Engineering roles.
- Should be able to read/write and follow procedures.
- Must have good verbal and written communication skills to work with onsite/external audiences.
- Should have knowledge of Calibration and Maintenance Practices in a Manufacturing or Life Sciences setting.
- Effective interpersonal skills to work with suppliers, peers, and other functional areas.
- The ability to prioritize multiple competing deliverables simultaneously.
- Must be able to work unsupervised or in a team atmosphere.
- Proficient in Office Suites and data management tasks for lookups, pivot tables and charting.
- Report writing or SQL for DB2 a plus.
- No Travel required.
- Must be able to walk in hallways and climb stairs and carry boxes 20 lbs or lighter
Physical Requirements:
- None
NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
Additional Information:
The US base salary range for this full-time position is $72,400.00 - $102,947.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
johnandkristie.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, johnandkristie.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, johnandkristie.com is the ideal place to find your next job.