Senior Quality Engineer, Human Factors
Company: Olympus Corporation of the Americas
Location: Westborough
Posted on: March 17, 2023
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Job Description:
Working Location: MASSACHUSETTS, WESTBOROUGH
Are you looking for a company that cares about people's lives and
health, including yours? At Olympus, we help make people's lives
healthier, safer and more fulfilling, every day.
Let's inspire healthier lives, together.
Job Description
The Design Assurance Engineer is responsible for contributing to
the design, development and management of projects for legacy
products and support of new products under development. The Design
Assurance Engineer provides organizational support with a focus on
Design Quality activities. Works with internal/external
manufacturers providing finished products, services, components,
and sub-assemblies to ensure compliance with company policies and
procedures and medical device regulations. The Design Assurance
Engineer will partner with Operations, R&D, Supply Chain and
other departments to continuously improve products and processes
that meet all internal and external requirements and
regulations.
Job Duties
Assist in the design & execution of Production Release Process
(PRP) project for components & finished devices.
Lead and implement complex projects including quality improvement
initiatives.
Knowledge of basic statistical methods (e.g., hypothesis testing,
DOE, ANOVA, R&R studies, capability, tolerance interval
analysis, power and sample size determinations, etc.).
Demonstrate basic project management skills and interact with
cross-functional teams.
Knowledge of risk assessment tools (e.g., ISO 14971, FMEAs,
FTA).
Lead Process/Design Risk Analysis.
Working knowledge of Post Market Surveillance.
In-depth knowledge of Quality Engineering principles and
methodologies. In-depth knowledge of Design Controls, CAPA, NC,
etc.
Coordinate and lead metrology support as needed, including gage
R&R.
Provide leadership in understanding of the quality regulations to
other disciplines.
Support and lead multiple product Design Control activities for new
product development efforts. Support Process/Design
Validation/Verification activities and approach including software
validation.
Lead implementing limited cost of quality concepts, including cost
of quality, data collection, & reporting.
Support Manufacturing Engineering in the creation of DMR, DHR,
routes, and bills of material, print changes, and specifications
for inhouse / external manufacturing.
Conduct Internal Audits of the Quality System. Conduct audits of
new suppliers as part of the project teams.
Communicate effectively at all levels within Quality as well as
cross functionally with departments such as PD, Regulatory,
Sales,
Supply Chain and Marketing in order to provide quality input.
Perform other related duties as assigned by management.
Know and follow all laws and policies that apply to one's job, and
maintain the highest levels of professionalism, ethics and
compliance at all times.
Job Requirements
REQUIRED QUALIFICATIONS:
Bachelor's Degree in Engineering required.
Minimum of 2-4 years (minimum of 2 years with Masters Degree) years
of experience in process quality engineering with an emphasis on
Supplier Quality Management within an FDA regulated medical device
manufacturing environment.
Proficient with DMAIC / Black Belt / Six Sigma type tools to
analyze, drive root cause, and solve problems.
Knowledge of statistics, sampling strategies, and design of
experiments, including statistical software tools such as
Minitab.
Knowledge with process trouble shooting of parts utilizing
injection and insert molding, extrusion, stamping, wire EDM, and
CNC machining.
Understanding of the design, development, and tolerancing of
complex systems.
Knowledge of Risk Management practices, Corrective and Preventative
Actions, and regulatory requirements such as FDA QSR's, ISO 13485,
ISO 14971, & ISO 11135.
Internal: Must interact to some degree with almost every department
in the company. Most often interacts with upstream marketing,
quality assurance, research & development, regulatory, and
manufacturing.
External: Some contact with customers, consultants, surgeons,
product users, patients, and suppliers, including domestic and
international travel.
For Organization Influence: Work directly with manufacturing and
research & development engineering in fabrication of prototypes for
new product, modifications, and/or improvements. Work with
manufacturing personnel in implementation of new products. Work
with marketing on design of new products
Must be able to manipulate micro-size components with fingers.
Requires use of hands and arms to operate computer, printer,
telephone, and develop drawings.
Requires the ability to communicate on a telephone.
Requires ability to see miniature and micro-size components, as
well as, use of magnifying devices and microscopes.
Requires visual ability to withstand hours of computer work.
PREFERRED QUALIFICATIONS:
Strong written and oral communication skills are required.
Self-motivated with a strong sense of urgency.
Proficient in most common PC based applications (Word, Excel,
PowerPoint, Project, & Visio), including Agile PLM.
We realize work isn't just a job to you.
It's a big part of your life, but not the only part. That's why we
offer competitive salaries, a robust 401(k) program, annual bonus
program and comprehensive medical benefits, as well as tuition
reimbursement, flexible schedules, parental and adoption leave,
on-site services and Colleague Affinity Networks - so you can be
ready for where life can take you.
Olympus requires all new hires to be "fully vaccinated" against
COVID-19, as defined by the Centers for Disease Control and
Prevention (CDC), on or before their first day of work. Individuals
who have been offered employment who have a disability, medical
condition, or sincerely-held religious belief that prevents them
from being vaccinated against COVID-19 are required to request and
be granted a reasonable accommodation prior to their first day of
work.
Olympus is passionate about the solutions it creates for the
medical, life sciences, and industrial equipment industries, as
well as cameras and audio products. For more than 100 years,
Olympus has focused on making people's lives healthier, safer and
more fulfilling by helping detect, prevent, and treat disease,
furthering scientific research, ensuring public safety, and
capturing images of the world.
Olympus' Medical business uses innovative capabilities in medical
technology, therapeutic intervention, and precision manufacturing
to help healthcare professionals deliver diagnostic, therapeutic,
and minimally invasive procedures to improve clinical outcomes,
reduce overall costs, and enhance the quality of life for patients.
Olympus' Medical portfolio includes endoscopes, laparoscopes, and
video imaging systems, as well as surgical energy devices, system
integration solutions, medical services, and a wide range of
endotherapy instruments for endoscopic and therapeutic
applications. For more information, visit www.olympus-global.com
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Olympus---True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and
advancement opportunity to all applicants and employees without
regard to race, color, national origin (including language use
restrictions), citizenship status, religious creed (including dress
and grooming practices), age, sex (including pregnancy, childbirth,
breastfeeding, medical conditions related to pregnancy, childbirth
and/or breastfeeding), gender, gender identity and expression,
sexual orientation, marital status, disability (physical or mental)
and/or a medical condition, genetic information, ancestry, veteran
status or service in the uniformed services, and any other
characteristic protected by applicable federal, state or local
law.
Posting Notes: -- United States (US) -- Massachusetts (US-MA) --
Westborough --
Keywords: Olympus Corporation of the Americas, Worcester , Senior Quality Engineer, Human Factors, Engineering , Westborough, Massachusetts
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