Senior Quality Engineer

Nova Biomedical:
One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Job Summary:

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.

Responsibilities:

* Provide expertise and general oversight for the management of Nova Biomedicals 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 Biomedicals 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.

Experience Requirements:

* Strong working knowledge of ISO
13485, ISO
14971, MDSAP, and FDA Regulations (21

CFR Part
820).

* 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.

* 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.

Physical Requirements and

Working Conditions:

* Ability to stand, walk, and move for extended periods.

* Ability to lift and carry up to [2550] pounds as required.

* Ability to perform repetitive physical tasks.

* Ability to bend, reach, stoop, or climb as needed.

* Ability to work in varying environmental conditions (e.g., noise, temperature, equipment).

* Ability to operate tools, machinery, or technical…