Quality Engineer II

NOVA Biomedical GmbH; Billerica (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the medical device sector seeks a Quality Engineer II to enhance its Quality Management System. This role involves compliance with ISO standards, internal audits, and fostering quality improvements. Ideal candidates will possess a BS degree and 1-2 years of relevant experience, offering opportunities to thrive in a collaborative environment.

Benefits

Blue Cross Blue Shield medical plan

Tuition reimbursement

Matching 401K

Innovative scholarship program for children of employees

Qualifications

• 1-2 years of quality engineering experience in medical devices or biotechnology.
• BS degree in engineering, sciences, or technical field.

Responsibilities

• Maintain compliance with ISO standards and manage quality system improvements.
• Conduct internal investigations and audits, and support regulatory inspections.
• Participate in continuous improvement projects and manage quality data.

Skills

Communication

Statistical analysis

Problem solving

Technical document interpretation

Advanced math

Quality assurance knowledge

Education

BS degree in engineering or sciences

Tools

Minitab

Microsoft Office

Job description

Career Opportunities with Nova Biomedical Corporation

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 Quality Engineer II in our Manning Road, Billerica, MA facility. This role will support Quality Assurance activities within the corporate Quality Management System (QMS). Responsibilities include providing expertise and general oversight for the management and improvement of design and development, validations, quality planning, internal auditing, investigations, process controls, change management, quality records, corrective and preventive activities, data management, employee training, and other duties as assigned.

Essential Responsibilities and Accountabilities:

• Maintain and improve the Quality System to ensure compliance with ISO standards, QSR Regulations, and MDSAP.
• Provide front and backroom support during external regulatory body audits and factory inspections such as FDA, TUV, Partners, and Customers.
• Participate in Nova's Internal Quality Auditing program.
• Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements.
• Drive Quality Planning activities in support of new product launches and Quality System improvements.
• Participate in problem-solving activities to determine root cause and effective corrective action and other CAPA activities.
• Perform and assist with internal investigations (NIRs) for customer complaints and/or deficiencies identified internally.
• Review and approve nonconforming material reports, artwork proofs, and First Article Inspections.
• Create and update Standard Operating Procedures (SOPs).
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV).
• Participate in the identification, planning, implementation, and monitoring of continuous improvement projects to reduce defects and improve overall product quality.
• Manage and maintain quality data including design and validation of new or existing databases, queries, and reports.
• Prepare, present, review, and analyze quality data with SMEs to identify trends and draw effective conclusions.
• Provide general oversight and training on Quality procedures and practices.

Qualifications:

Certifications are not required but Certified Quality Auditor and/or Certified Quality Engineer is a plus.

Skills and Competencies:

• Excellent oral and written communication.
• Read and interpret technical documents.
• Exercise judgement in selecting methods and techniques for obtaining results and problem solving. Advanced math skills and sound understanding of statistical analysis; previous experience with Statistical software (e.g., Minitab) is a plus.
• Advanced computer knowledge and proficiency with Microsoft Office tools. Basic knowledge of FDA QSR, MDSAP, IVDD/IVDR, and ISO 13485.

Education:

BS degree in engineering, the sciences, or another technical discipline.

Experience:

1-2 years of quality engineering experience in the medical device and/or biotechnology fields, or equivalent.

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.