UL - Quality Systems Engineer

Ultralife Corporation is a leading provider of advanced, highest quality products and services ranging from power solutions to communications and electronics systems to customers across the globe in the government & defense, medical, safety & security, energy, industrial and robotics sectors.

We are a global business with strategic locations in the Americas, Europe, and Asia, ideally positioned to service global customers.

The Quality Systems Engineer will serve a key role in the Battery & Energy Products (B&EP) organization by leading teams and successfully developing, implementing, maintaining and continuously improving, effective quality systems. The position requires a proven, natural leader, with solid manufacturing/engineering experience, who can demonstrate the ability to collaborate in a pro-active, hands-on manner across the organization.

Essential Functions:

• Support the design, qualification and ensure ongoing manufacturing of products that meet or exceed internal, customer, regulatory and other applicable requirements.
• Coordinate external QMS registration and surveillance audits to ensure continuing registration to applicable ISO standards.
• Represent Quality Department during customer, regulatory and 3rd-party audits of manufacturing operations and the QMS.
• Fulfill the Quality Department responsibilities for customer complaint investigation and response through the Return Material Authorization (RMA) process. Collaborate with manufacturing and product engineers on failure analysis. Coordinate with Sales and senior management on customer communications.
• Manage corrective and preventive action processes and maintain CAR and PAR status report, records and supporting documents.
• Partner with the Quality Director and other key personnel to maintain and update Ultralife’s quality management system to ISO, FDA QSR, FAA and other applicable requirements.
• Coordinate 3rd-party internal audits of QMS to ensure continuing conformance to applicable ISO standards; including response and closure of audit findings.
• Collaborate with manufacturing team and use quality improvement tools/methods to drive focused defect reduction efforts.
• Manage and maintain quality inspection and product release processes for finished goods.
• Monitor, support and promote process validation activities for new product introductions and current manufacturing operations.
• Support new product development teams in the creation of requirements documents, specifications and qualification test plans.
• Facilitate risk analysis and control throughout product realization (i.e. from concept to finished good); particularly in support of ISO 13485 requirements. Includes active participation and leadership of DFMEA and PFMEA activities, control plan development and authoring of manufacturing test/inspection procedures.
• Actively participate in new product development teams and serve as a key technical contributor to successful transition to production.

Education and Experience:

• Proven record of experience in the medical device industry in development and implementation of quality systems, process controls and continuous improvement methodologies; electronics and medical device manufacturing preferred
• Knowledge and working application of process validation principles, guidelines and industry practice
• Knowledge and working application of production control systems (e.g. SPC, MES)
• Knowledge and working application of risk management methodologies (e.g. DFMEA, PFMEA)
• Knowledge and working application of quality management system requirements, in particular ISO 9001 and ISO 13485; familiarity with FDA QSR preferred
• Solid technical understanding of manufacturing engineering principles and statistical analysis
• Internal Quality System auditing experience, especially ISO 13485 and FDA QSR
• Ability to multi-task and methodically manage multiple projects
• Ability to work effectively both independently and in teams across organizational levels
• BS in Quality, Engineering or similar degree preferred
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
• Minimum 7 years’ experience in product development or manufacturing environment
• Strong written and verbal communication skills
• Knowledge of Lean manufacturing, Six Sigma Certification preferred
• High level of drive and initiative, flexibility and strong work ethic

This job description is intended to convey information essential to understanding the scope of the position described above and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position.

Ultralife Corporation is an Equal Opportunity Employer, and as such affirms the right of every person to participate in all aspects of employment without regard to race, color, religion, sexual orientation, gender identity, national origin, citizenship, sex, age, veteran status, disability, genetic information, or any other protected characteristic. If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department via phone at 315- 332-7100