Job Summary: 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.
Responsibilities: - 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.
Skills & 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.
Experience Requirements: BS degree in engineering, the sciences, or another technical discipline.
1-2 years of quality engineering experience in the medical device and/or biotechnology fields, or equivalent.
Physical Requirements and Working Conditions: - Comfort with working at a computer for extended periods.
- Capacity to lift and carry up to [25-50] pounds as required
- Able to communicate effectively via phone, video, and written communication.
- Occasional need to move about the office to access meetings or resources.
- Ability to work at a desk
Why Work for Nova Biomedical - Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
- Company subsidized cafeteria in our Waltham, MA office
Work Location: work schedule on-site in 5days/week on-site
Targeted Salary Range: $85,000 - $105,000/yr
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
