Description For Senior Quality Engineer
We are seeking a Senior Quality Engineer to join our Quality team. This role plays a critical role in ensuring our innovative products are designed, developed, and manufactured to the highest standards of quality, safety, and regulatory compliance.
Major duties and responsibilities
We are seeking a Senior Quality Engineer to join our Quality team. This role plays a critical role in ensuring our innovative products are designed, developed, and manufactured to the highest standards of quality, safety, and regulatory compliance.
Inventory Management
‣ Support and continuously improve the Quality Management System (QMS), including the Quality Manual, Standard Operating Procedures (SOPs), work instructions, forms, and quality records.
‣ Lead initiatives to improve quality processes while ensuring compliance with FDA, ISO, and company requirements.
‣ Support Management Review activities by preparing quality metrics, trend analyses, and recommendations.
‣ Serve as the Quality representative on cross-functional product development teams from concept through commercialization.
‣ Lead Design Assurance activities in accordance with Design Controls (21 CFR Part 820/ISO 13485), including: design reviews, design verification & validation; design transfer, and Design History File (DHF) documentation.
‣ Ensure appropriate application of risk management principles throughout the product lifecycle in accordance with ISO 14971.
‣ Review design changes and evaluate quality, regulatory, manufacturing, and risk impacts.
‣ Partner with Operations and Manufacturing Engineering to improve manufacturing processes, product quality, and operational efficiency.
‣ Lead investigations of production quality issues using structured problem-solving methodologies.
‣ Assess impacts of design and process changes on: DFMEA, PFMEA, process controls, control plans, inspection methods.
‣ Develop statistical sampling plans and acceptance criteria.
‣ Lead Nonconformance (NCR) investigations and Corrective & Preventive Action (CAPA) activities.
‣ Verify effectiveness of corrective actions and ensure timely closure.
‣ Identify recurring trends and recommend systemic improvements.
‣ Partner with Supply Chain to qualify, monitor, and improve supplier performance.
‣ Participate in supplier evaluations, audits, and performance reviews.
‣ Review supplier quality metrics and drive corrective actions when performance expectations are not met.
‣ Support incoming inspection strategies and supplier quality agreements.
‣ Lead or support equipment qualification and process validation activities including: IQ, OQ, PQ.
‣ Review and approve validation protocols and reports.
‣ Ensure calibration and preventive maintenance activities comply with QMS requirements.
‣ Review and approve Engineering Change Orders (ECO/DCO).
‣ Ensure product and process changes are appropriately documented, validated, and implemented.
‣ Support cross-functional implementation of engineering and manufacturing changes.
‣ Lead and participate in: internal audits, supplier audits, FDA Inspections, ISO Certification Audits, and Notified Body Audits.
‣ Support responses to audit observations and implementation of corrective actions.
‣ Ensure ongoing compliance with applicable domestic and international regulations.
‣ Analyze quality metrics and statistical trends to proactively identify opportunities for improvement.
‣ Drive Lean Manufacturing and Continuous Improvement initiatives.
‣ Utilize statistical tools to improve product quality and manufacturing capability.
‣ Develop dashboards and Key Performance Indicators (KPIs) that measure quality system effectiveness.
‣ Mentor and provide technical guidance to Quality Engineers, Inspectors, and cross-functional teams.
‣ Lead cross-functional quality improvement projects.
‣ Influence quality decisions across Engineering, Operations, Regulatory Affairs, Clinical, and Manufacturing.
‣ Promote a culture of quality throughout the organization.
Requirements
Education requirements
Bachelor's degree required, preferably in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering or related engineering disciplines.
Experience requirements
Minimum 7–10 years of Quality Engineering experience in the medical device industry. Minimum 5 years supporting FDA-regulated medical device manufacturing. Experience supporting both New Product Development and commercial manufacturing. Demonstrated experience leading cross-functional quality initiatives. Medical device startup experience. Experience supporting Class II and/or Class III medical devices. Experience with process validation methodologies. Excellent project management and organizational skills. Ability to influence without direct authority and lead cross-functional teams. Excellent written, verbal, and presentation skills. Strong interpersonal and collaboration skills. Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Excellent verbal and written communication skills are required. Ability to work cross-functionally to achieve company goals and quality objectives. Excellent interpersonal, organizational, communication & leadership skills Knowledge of Statistics and ASTM test methods preferred Thrive in a fast-paced and dynamic work environment Strong oral and written communication skills. Demonstrated proficiency utilizing problem solving tools (i.e., FMEA, DOE, SPC, etc.) and application of statistical techniques is desired.
Physical requirements
Ability to stand, walk, or sit for extended periods. Capacity to move between work areas, including offices, production floors, and warehouses.
Required skills/abilities
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
- Excellent verbal and written communication skills are required.
- Ability to work cross-functionally to achieve company goals and quality objectives.
- Excellent interpersonal, organizational, communication & leadership skills • Knowledge of Statistics and ASTM test methods preferred
- Thrive in a fast-paced and dynamic work environment
- Strong oral and written communication skills.
- Demonstrated proficiency utilizing problem solving tools (i.e., FMEA, DOE, SPC, etc.) and application of statistical techniques is desired.
Manual dexterity
- Lifting up to 50 lbs.
Occasional PPE
- Pay: $28.00 - $38.00 per hour
- Expected hours: 40.0 per week
Benefits
401(k)
Dental insurance
Disability insurance
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance
- Work Location: In person