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 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) for 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.
- Perform DHR reviews to support complaint responses.
- Validate and maintain testing spreadsheets.
Experience Requirements: - Bachelor's degree or higher in Engineering or the technical sciences, or equivalent experience.
- 8+ years Medical Device/IVD Experience as a Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company.
- Strong working knowledge of ISO13485, ISO14971, 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 is a plus.
- Experience performing and reviewing PFMEAs, Risk Analysis, and Validation Plans.
- Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC).
- Experience with 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.
- Work 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. ASQ Certification as Medical Device Auditor is a plus.
- ASQ Certification as Quality Engineer is preferred.
Physical Requirements and Working Conditions: - Able to stand, walk, and move for extended periods.
- Capacity to lift and carry up to [25• 50] pounds as required.
- Comfort with performing repetitive physical tasks.
- Able to bend, reach, stoop, or climb as needed.
- Willingness to work in varying environmental conditions (e.g., noise, temperature, equipment).
- Proficiency in operating tools, machinery, or technical equipment.
- Use of appropriate personal protective equipment (PPE) required.
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: Hybrid work schedule on-site in Lexington Road, Billerica, [4-5] days/week on-site
Targeted Salary Range: $125,000 - $135,000/year.
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.
