Nova Biomedical is hiring a Sr. Quality Engineer/ Supervisor who will be responsible for providing 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. Provide troubleshooting guidance for quality personnel. Develop and implement process improvements to improve yield and overall product quality.

Essential Responsibilities and Accountabilities:

• 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.
• 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 and Corrective and 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 the 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.

Interaction:

Interfaces with R&D, PLQC Teams, QA, QC, Post Market Surveillance, Manufacturing, Manufacturing Engineering, Technical Suppoti, Purchasing, Supplier Quality, Incoming Inspection, and Distribution. Also work directly with external customers and partners.

Qualifications:

• Strong working knowledge of !SO13485, 1SO14971, 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.

Skills and Competencies

• 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.

Education:
Bachelor's degree or higher in Engineering or the technical sciences

Experience:
8 plus years Medical Device/I VD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company.

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, and an innovative scholarship program for children of employees.