Senior Quality Engineer
Company: Olympus Corporation of the Americas
Posted on: April 8, 2021
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 Senior
Supplier Quality Engineer is responsible for providing support with
a focus on supplier quality management activities. Works with
external manufacturers and suppliers providing finished products,
services, components, and sub-assemblies to ensure compliance with
company policies, procedures, and medical device regulations. The
Senior Supplier Quality Engineer will partner with Manufacturing
Engineering, Operations, R&D, Supply Chain and other
departments to continuously improve products and processes that
meet customer and patient requirements. Job Duties * Lead supplier
quality management for legacy products and support of new products
under development per OSTA new product development (NPD)
-- * Lead component inspection plans, first article inspection
reports (FAIR's), and issue resolution (collaborate with Design
Assurance or Quality Engineering, if design or process
-- * Lead corrective & preventive actions (CAPA's), supplier
corrective action requests (SCAR's), and supplier notifications
only (SNO's) to resolution, including monitoring, analyzing, and
reporting on supplier performance data and metrics.
-- * Lead the evaluation of new or transferred suppliers and/or
changes to the Approved Supplier List (ASL).
-- * Lead post-launch supplier sourcing sustainment.
-- * Notify and present high impact to business SCN's to Local
Review Boards via Product Release Process (PRP).
-- * Support supplier process management, i.e., risk management,
quality assurance agreements, control plans, supplier assessments /
audits (QS status), submitted validations (IQ, OQ, PQ, PPQ),
process failure modes and effects analysis (pFMEA), and supplier
inspection plan / method evaluations.
-- * Collaborate and approve supplier sourced component and
subassembly specifications and/or drawings.
-- * Utilize effective and efficient Quality Engineering techniques
such as risk analysis, statistical--data analysis, process
capability analysis, design of experiments, measurement system
analysis, control plans, and development of sampling plans
throughout the product lifecycle.
-- * Author, collaborates and approve quality system documentation
via Agile PLM.
-- * Perform other duties as assigned by management. Job
Requirements REQUIRED QUALIFICATIONS: * Bachelor's Degree in
Engineering required. Experience can be substituted for education
requirements. * Minimum 5 years of experience in process quality
engineering in Medical Device Industry. * Prefer experience 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.Proficient with statistics, sampling strategies,
design of experiments, process capability, including statistical
software tools such as Minitab. * Strong written and oral
communication skills are required. PREFERRED QUALIFICATIONS: *
Master's Degree preferred. * Proficient 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 are required. * Ability to lead, champion change, and
execute strategies to meet goals. * Must be self-motivated with a
strong sense of urgency and ability to deliver on required
activities. * Must have a sense of ownership and a desire to follow
a project from inception to full production. * Proficient in most
common PC based applications (Word, Excel, PowerPoint, Project, &
Visio), including Agile PLM.-- * ISO 13485 Lead Auditor
certification is preferred. * ASQ Certification (CQE & CBA) is
preferred. 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 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 .
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) -- Washington (US-WA) --
Keywords: Olympus Corporation of the Americas, Redmond , Senior Quality Engineer, Engineering , Redmond, Washington
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