Collaboration drives Nordson's success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.
Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart. Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL works with doctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond.
Essential Job Duties and Responsibilities
Assure compliance with FDA Quality System Regulation, ISO Standards and SOP's as defined by Nordson's policies, practices, and procedures.
Lead Lean Quality system improvement-Process mapping to identify Opportunities Innovation, Cost reduction savings activities, Value Stream Improvement and Continuous overall improvement in quality-FTQ-lead.
Quality System Operational Excellence- Eliminate All Escapes. Metric goal is zero. 15% improvements on complaints.
Interact with the customer and have broad knowledge to understand customer needs and wants.
Represent Quality in production process efforts, product devloipment, quality planning, FMEA and Risk Analysis.
Participate in IQ/OQ/PQ validation activities including the drafting, review, and execution of protocols if is needed.
Conducts investigations with its engineers related to CAPA,Complaints and Internal/external audit activities.
Handle customer complaints including the implementation of problem-solving actions to ensure product quality. Maintain all required documentation for closure.
Apply statistical tools such as Process Capability, Measurement System Analysis and Statistical Process Control to assess and improve production processes.
Provide strategic projects direction to identify gaps in process and takes action to address them.
Review product and process changes to ensure proper documentation and actions related to risk assessment are complete.
Train Quality Assurance Inspectors and manufacturing personnel in understanding specifications, new product, procedures and measurement techniques.
Apply Quality Engineering techniques on new and existing products. Assure all products meet or exceed customer requirements.
Lead or participate in internal/external Quality System audits.
Maintain effective working relations, communications and feedback with all other departments.
Lead and develop Quality Engineering and technical staff.
Implementation of SPC in all areas.
Risk reduction-less rework- decrease Internal and External Rejections- Reduce scrap from non-detection.
Quality Program-Be part of Quality Culture program recognition.
Documentation Review and Approval-Incoming Inspection Review-Calibration Records Review-DCN Review-TDN review approval if is needed.
Drive Cost of Poor Quality (COPQ) strategy and reduction across the areas.
Other duties as assigned, verbal and written.
Education and Experience Requirements
Bachelor's degree (desirable) and three to five years of relevant experience in the medical device industry or equivalent combination of education and experience.
Working knowledge & Internal Quality System Auditing experience for medical devices (ISO 13485), US FDA Quality System Regulation (21 CFR 820), and relevant international standar.
Advanced knowledge of Lean Manufacturing.
Good understanding on statistical analysis, process control, statistical decision making, DOE.
Experience on internal and external audits
ASQ Certified Quality Engineer a plus.
Preferred Skills and Abilities
Analytical skills, and problem-solving techniques.
Good decision-making skills -Product and process development- Risk management.
• Good organizational skills, including attention-to-detail and appreciation of deadlines.
• Ability to work well under pressure, to handle multiple projects, and to meet aggressive deadlines.
• Proficient in use of MS Word, Excel and PowerPoint.
• Generate reports using data analysis, SPC analysis/tools, Minitab etc.
Working Conditions and Physical Demands
While performing the duties of this job, the employee is regularly required to stand, walk and use hands and fingers, handle or feel, frequently required to talk or hear, sit, reach with hands and arms, climb or balance, stoop, kneel and crouch.
Specific vision abilities required by this job include close vision, (vision 20/20, or corrected 20/20 is a plus).
The employee must be willing and able to travel
Ability to use special protection devices for ears and eyes at the same as gloves for hands.
Equal Opportunity Statement
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment requirements consistent with applicable laws.
#LI-NS1 Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.