Quality Engineer II

Posted 6 Days Ago
Be an Early Applicant
Salem, NH, USA
In-Office
Mid level
Industrial • Manufacturing
The Role
Ensure manufacturing meets FDA and quality standards (ISO 13485, GMP). Lead root-cause analysis, CAPA, SPC, gage R&R, process and transfer validations. Manage supplier nonconformances (SCAR, MRB), respond to customer complaints, support audits, training, and continuous improvement to reduce COPQ, scrap, and escapes to customers.
Summary Generated by Built In

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Summary of the role

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.

Assure that manufacturing operations follow all Good Manufacturing Practices and Procedures as defined by insuring that FDA and Quality Standards are met.

•    Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified.
•    Design, execute and document gage R&R studies.
•    Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs). 
•    Actively lead process improvement events leading to reduction in cost of poor quality (COPQ).
•    Reduce scrap and manufacturing waste for various product lines throughout the factory.
•    Quality Representative for Material Review Board (NMR) for purchased and make components.
•    Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review)
•    Investigate and respond to customer complaints and customer issued SCARs.
•    Quality Representative for Process Validations and Transfer Validations (may require writing, reviewing, executing, analyzing and reporting on test protocols).
•    Prepare quality related deliverables in a timely manner.
•    Prepare and execute Engineering studies as needed.
•    Responsible for CAPA root cause investigation and actions implementation.
•          Implementation of SPC.
•          Eliminate All Escapes to the customer. Metric goal is zero.
•          Creates Controls plans
•          Meet KPI Goals,Quality deliverables.
•          Support Quality Culture.
•    .     Lean QMS initiative to reduce Muda by eliminating bureaucratic processes.
•    Participate in Quality and Manufacturing Department meetings.
•    Collaborate in the clarification of specifications for quality.
•    Acts as a consultant for areas related to his/her expertise.
•    Support  Supplier management process as required .
       Participate and assist as a part of the Internal Audit team as required.
•    Other duties as assigned, verbal and written.
•    Follow medical device manufacturing best practices (GMP, GDP, etc.), current Nordson Medical policies and procedures, ISO 13485, 21CFR Part 820 and other applicable regulations to ensure compliance to applicable customer and regulatory requirements
 

Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.

Skills Required

  • Knowledge of ISO 13485 and 21 CFR Part 820
  • Experience with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
  • Experience performing root cause analysis and CAPA management
  • Ability to design, execute, and document gage R&R studies
  • Implementation and use of Statistical Process Control (SPC)
  • Experience with supplier corrective actions (SCAR) and Material Review Board processes
  • Experience with process validations and transfer validations
  • Experience supporting or performing internal audits and Quality Management System activities
  • Lean QMS or continuous improvement experience focused on reducing waste/COPQ
  • Ability to prepare quality deliverables, work cross-functionally, and support manufacturing quality training

Nordson Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Nordson Corporation and has not been reviewed or approved by Nordson Corporation.

  • Retirement Support The 401(k) features automatic enrollment at 6%, a 50% match on up to 6% of pay, and an additional 3% company contribution for eligible U.S. employees even without employee contributions. Feedback suggests this retirement structure is above what many mid-size manufacturers offer.
  • Leave & Time Off Breadth Paid holidays and a typical year-end shutdown between Christmas and New Year’s at many U.S. locations expand time off beyond standard PTO. Feedback suggests this shutdown is a distinctive work-life perk, though availability can vary by site or business unit.
  • Wellbeing & Lifestyle Benefits Volunteer release time and a 3:1 charitable gift-matching program are offered alongside recognition programs, tuition assistance, and community initiatives. Feedback suggests these elements add value beyond core insurance and PTO.

Nordson Corporation Insights

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The Company
HQ: Westlake, OH
2,445 Employees
Year Founded: 1954

What We Do

Nordson is a team of 7,300 global employees thriving in an environment where they are supported and encouraged to be their best. Working side by side, we build meaningful connections with each other and our customers. Together, we deliver products that are solutions, and they’re likely touching your life every day. Have you ever changed a diaper? Opened a box of cereal? Used a smart phone or driven a car? Then we’ve already met. At Nordson, we take pride in being an outstanding corporate citizen and strongly believe in sharing our success with the communities where our employees live and work. Whether you’re working in one of our labs, offices or manufacturing facilities, your efforts will enable our customers to succeed and our company to continuously improve and grow. We engineer, manufacture and market differentiated products and systems used for precision dispensing and processing in a variety of end markets, from packaging to transportation and medical to electronics. Founded in 1954, we operate under the values of integrity, respect for people, customer passion, energy and excellence. Nordson is headquartered in the United States in Westlake, Ohio, and has direct operations in more than 30 countries to support our products and systems with application expertise and a direct global sales and service organization

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