UL - Quality Systems Engineer
Company: Ultralife Corporation
Location: Newark
Posted on: February 16, 2026
|
|
|
Job Description:
Job Description Job Description 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
Keywords: Ultralife Corporation, Rochester , UL - Quality Systems Engineer, Engineering , Newark, New York