Senior Quality Engineer

Nova Biomedical Corporation • Billerica, MA

10d • Hybrid

About The Position

The 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.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• Provide expertise and general oversight for the management 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.
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions.
• Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate.
• Format, manage and maintain 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.
• Support Quality Plan activities in support of company projects.
• Design and validate queries and reports for data from Production, Non-Conforming Materials, Field Return Investigation, and Corrective & Preventive Actions on the Database.
• Analyze data and generate reports to identify trends and to draw effective conclusions.
• Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements.
• Ensure that validation activities are appropriate to their needs and in alignment with Nova Biomedical’s procedures.
• Identify and implement problem-solving activities to determine root cause and effective corrective action.
• Assist management with improving Quality Systems and increasing plant-wide compliance with appropriate regulations.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed