Nova Biomedical is looking for a hands-on Quality Engineer I on-site in our Waltham, MA facility to provide Quality Engineering support to ensure that Quality practices are implemented and maintained as part of design transfer, incoming inspection, planning, production, data trending and monitoring. You will also provide troubleshooting guidance for Quality personnel as well as develop and implement process improvements to improve yield and overall product quality. More specific responsibilities will include:
- Providing expertise and general oversight for the management and improvement of Nova Biomedical's Quality Systems, including quality planning, quality control planning, internal auditing, inspection procedures, document controls, change management, process controls, quality records, corrective and preventive activities, validations, and data management.
- Preparing and reviewing Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions.
- Formatting, managing and maintaining Quality Control Plans and PFMEAs for new and existing products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing and that any significant process updates are properly reflected.
- Supporting Quality Plan activity in support of company projects.
- Designing and validating queries and reports for data from Production, Non-Conforming Materials and Corrective and Preventive Actions on the Database.
- Analyzing data and generating reports to identify trends and to draw effective conclusions.
- Generating and reviewing Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements.
- Ensuring that validation activities are appropriate to their needs and in alignment with the Nova Biomedical 's procedures.
- Identifying and implementing problem-solving activities to determine root cause and effective corrective action.
Qualifications/Skills and Competencies:
- Excellent oral and written communication skills, prioritization, and multi-tasking skills.
- Knowledge of manufacturing processes and their associated risk to product.
- Knowledge of regulations and standards affecting IVDs and Medical Devices (ISO 9001, ISO 13485, ISO 14971).
- Detail-oriented, ability to read and interpret technical documents.
- Team-oriented, ability to work well with multi-disciplined team and understanding task requirements.
- Ability to exercise judgement in selecting methods and techniques for obtaining results.
- Computer literacy including MS Word, MS Excel, MS Access, and MS Power Point.
- Statistical software experience, i.e. Minitab.
Education/Experience:
- Bachelor's degree or higher in Engineering is required (Mechanical Engineering preferred).
- 0-2 years of experience in a regulated, manufacturing environment preferred.
- Experience performing validations (IQ, OQ, PQ) of manufacturing/quality equipment, processes, and/or test methods is a plus.
At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.
Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.
