Description For Quality Engineer
We are seeking a 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
Quality System Management
‣ Support the maintenance of the Quality Management System, including the Quality Manual and associated procedures.
‣ Participate in cross-functional teams to support quality disciplines, decisions, practices, and in the development of protocols to ensure appropriate selection of sampling plans.
‣ Collaborate with Operations to resolve product quality issues, assess impact on DFMEAs and PFMEAs from design and process changes, and on product and process improvement as well as efficiency of inspection activities.
‣ Support design control efforts with cross-functional teams according to appropriate QMS processes and regulatory requirements.
‣ Review NCRs and CAPAs, support root cause analysis determination and investigations.
‣ Work with Supply Chain and suppliers to maintain high quality level of incoming production materials, including monitoring of suppliers per associated QMS procedure.
‣ Support process validations (IQ, OQ, PQ) by reviewing test protocols/reports and related documentation.
‣ Support the qualification and maintenance of equipment per associated QMS procedures, including calibration activities.
‣ Help manage document change orders (DCO) for product design, process updates, and regulatory changes.
‣ Support cross-functional teams in the implementation and communication of changes.
‣ Support incoming inspection activities, including inspecting incoming materials and reviewing inspection records per associated QMS procedures.
‣ Assist in maintaining inventory controls for materials, components, and finished goods.
‣ Monitor and trend quality data to identify potential quality issues.
‣ Support internal and external audits by participating in preparation activities and addressing audit findings.
‣ Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
Requirements
Education requirements
Bachelor's degree required, preferably inengineering
Experience requirements
Minimum 3-5 years experience in a medical device, start-up environment
Demonstrated experience with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971
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