Hybrid Senior Quality Engineer: Lead Quality Systems

novabio; Norwood (MA); Hybrid; USD 110,000 - 130,000; Full time

Job summary

Nova Biomedical is seeking a Senior Quality Engineer to provide Quality Engineering support across design transfer, inspection, production, and data monitoring. You will lead quality initiatives and ensure quality systems are integrated into all operations.

The role requires a engineering degree, 7+ years in Medical Device/IVD QA (or 4+ as Senior QE), experience with FDA regulations and ISO standards, plus strong communication and data analysis skills.

Qualifications

• Bachelor's degree in Engineering or technical sciences.
• 7+ years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company.
• Knowledge of regulations and standards affecting IVDs and Medical Devices (ISO 9001, ISO 13485, & ISO 14971, IVDR) and the ability to interpret regulations and apply appropriately
• Experience in FDA regulated environment.
• Excellent oral and written communication skills, prioritization, and multi-tasking skills
• 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 and certification is preferred.

Responsibilities

• Provide 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.
• Develop plans to resolve quality issues and use communication and analytical skills to generate support for changes. Effectively communicate with leadership to weigh pros and cons of changes and present solutions that meet business and quality/compliance needs.
• Mentor quality engineers
• Make risk-based decisions confidently
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions.
• Design and validate queries and reports for data from Production, Non-Conforming Materials and Corrective and Preventive Actions on the Database.
• Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate.
• Format, manage and maintain Quality Control Plans and PFMEAs for new products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing.
• Review and analyze specifications relating to acceptance activities.
• Support Quality Plan activities in support of company projects.
• 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.
• Participate in external audits and where appropriate interact directly with auditors to address concerns and answer queries.
• Ensure that validation activities are appropriate to their needs and in alignment with Nova Biomedical’s procedures.
• Maintain and oversee the Nova Biomedical Validation File and Log (a Microsoft Excel file) and the Nova Biomedical Validated Spreadsheet Log (Excel) and File.
• Identify and implement problem-solving activities to determine root cause and effective corrective action.
• Quality Management Review: Contribute to the information gathering for the QMS management review process.
• Assist management with improving Quality Systems and increasing plant-wide compliance with appropriate regulations.
• Proactively identify quality system gaps and develop solutions to close gaps, leveraging existing quality systems.

Skills

Excellent communication

Detail-oriented

Multi-tasking

Medical Device QA experience

Education

Bachelor's degree in Engineering or technical sciences

Tools

MS Word

MS Excel

MS Access

Power BI

Job description

Nova Biomedical is seeking a Senior Quality Engineer to provide Quality Engineering support across design transfer, inspection, production, and data monitoring. You will lead quality initiatives and ensure quality systems are integrated into all operations.

The role requires a engineering degree, 7+ years in Medical Device/IVD QA (or 4+ as Senior QE), experience with FDA regulations and ISO standards, plus strong communication and data analysis skills.