Role OverviewThe Senior Quality Engineer will provide Quality Engineering support to ensure that quality practices are effectively implemented and maintained across design transfer, incoming inspection, production, field returns, and data monitoring. This role will also support Engineering by offering troubleshooting guidance and will lead process improvement initiatives to enhance yield and overall product quality.
What You Will Do
Provide expertise and general oversight for the management of Nova Biomedical’s Quality Systems, prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV), participate in and/or lead Product Line Quality Committees (PLQC), and design and validate queries and reports for data from Production, Non-Conforming Materials, Field Return Investigation, and Corrective & Preventive Actions on the Database.
Why It Might Be a Fit
Strong working knowledge of ISO13485, ISO14971, MDSAP, and FDA Regulations (21CFR Part820), thorough understanding of data trending techniques, and previous experience developing product and process trends and reporting to senior management.
Requirements
- Strong working knowledge of ISO13485, ISO14971, MDSAP, and FDA Regulations (21CFR Part820)
- Thorough understanding of data trending techniques
- Previous experience developing product and process trends and reporting to senior management
- Experience performing validations (IQ, OQ, PQ) of manufacturing/quality equipment, processes, and/or test methods
- Experience performing and reviewing PFMEAs, Risk Analysis, and Validation Plans
- Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC)
- Experience performing internal audits
- Excellent oral and written communication skills, prioritization, and multi-tasking skills
- Knowledge of manufacturing processes and their associated risk to product
- Detail-oriented, able to read and interpret technical documents
- Works well with multi-disciplined team and understand task requirements
- Ability to exercise judgement in selecting methods and techniques for obtaining results
- Computer literacy including MS Word, MS Excel MS Access
- Statistical Software experience, i.e. Minitab
- Previous experience working with Master Control and/or Power BI a plus
- Auditing experience is a plus
- Green Belt Six Sigma Certification is a plus
Benefits
- Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
- Company subsidized cafeteria in our Waltham, MA office
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