Senior Quality Engineer

NOVA Biomedical GmbH; Billerica (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the medical device industry is looking for a Senior Quality Engineer to oversee and manage quality systems. This role involves ensuring quality practices in design, inspections, and production while driving process improvements. The ideal candidate has a strong background in ISO standards, FDA regulations, and extensive experience in quality engineering.

Benefits

Blue Cross Blue Shield medical plan

Tuition reimbursement

Matching 401K

Scholarship program for children of employees

Qualifications

• 8+ years in Medical Device/IVD as a Quality Engineer or 4+ years as Senior Quality Engineer.
• Strong expertise in quality systems, validations, and data analysis.
• Green Belt Six Sigma Certification is a plus.

Responsibilities

• Manage quality systems, prepare reviews for Engineering Change Orders.
• Analyze data for trends, generate reports.
• Support Quality Plan activities for company projects.

Skills

ISO 13485

FDA Regulations

Data trending techniques

Statistical analysis

Communication skills

Detail-oriented

Education

Bachelor's degree in Engineering or technical sciences

Tools

Minitab

Master Control

Power BI

MS Word

MS Excel

MS Access

Job description

Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities.

Nova Biomedical is hiring a Senior Quality Engineer to provide quality engineering support to ensure that Quality practices are implemented and maintained as part of design transfer, incoming inspections planning, production. field returns, data trending and monitoring, provide troubleshooting guidance för engineering and develop and implement process improvements to improve yield and overall product quality.

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) för 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.

Qualifications/Skills:

• Strong working knowledge of ISO 13485. MDSAP, and FDA Regulations (2 1 CFR 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
• 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.

Education and Experience:

• Bachelor's degree or higher in Engineering or the technical sciences, or equivalent experience.
• 8+ years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated reagents, medical device, or IV D manufacturing company.

Physical Requirements:

• Ability to carry 20 lbs.
• Ability to wear PPE.

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.