Quality Engineer
Company: RCM Technologies
Location: Raynham
Posted on: May 9, 2022
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Job Description:
Reference # : 22-00372 Title : Quality Engineer Location :
Raynham, MA Position Type : Full Time/Contract Experience Level :
Start Date / End Date : 05/16/2022 / 05/31/2023 Description Job
Title: Quality EngineerJob Function: Support all processes related
to base business operationsJob Type: Long term Contract (1+
years)Location: Onsite/Remote hybrid Southwest of BostonAbout
RCM:RCM Life Sciences & IT is a leading provider of IT Business
Solutions and Engineering Services to over 1,000 clients in the
commercial and government sectors. RCM partners with clients to
define implement and manage a broad range of technologies across
multiple platforms, systems, and networks. Our broad geographic
presence ensures that a proven and reliable tactical and strategic
capability is available and deployable virtually everywhere in
North America.Scope of JobThe Quality Engineer supports all
processes related to base business operations (day to day
manufacturing of orthopedic implants) such as investigating process
and product failures/challenges, identifying and implementing
process improvement opportunities, partnering multi-functionally to
strategize on continuous improvement, capacity expansion,
corrective action development and implementation, sustaining
projects, and detailing and/or reviewing required quality system
documentation related to the above. In order to do so optimally
they apply comprehensive and diverse knowledge of engineering and
quality engineering principles and practices such as problem
solving, root cause analysis and investigation, risk management,
documentation, and communication skills.Primary Responsibilities
Investigates process and product failures/challenges, documents
investigations and implements corrections/corrective actions to
mitigate the root cause and improve detection and control. Finds
opportunities for process improvement and implementing
improvements/corrective and preventative actions related to
manufacturing processes by leading and participating on
multi-functional teams concentrating on the aforementioned.
Partners multi-functionally to ensure the accurate application and
documentation of risk management (implementation and maintaining).
Provide Quality Engineering support to multi-functional partners
such as those in operations, engineering (process & manufacturing),
supplier quality, and planning/procurement. Champions
multi-functional communication and team work and promotes proactive
quality in actions and behaviors. Serves as site support for all
internal and external regulatory and compliance audits. Delivers
and/or provides timely reviews/approval of quality records (NR,
CAPA IP/AP/EM, Audit AP/EM, customer complaints), and risk
documentation. Ensure compliance with all FDA, ISO, quality, safety
and environmental regulations. Strategizes validation and
verification approaches for projects and provides project
planning/management support, as required. Knowledge & Experience
Required: A minimum of 2 years of related experience Experience
working in an FDA regulatory environment in
manufacturing/operations The ability to perform "hands on "
troubleshooting and problem solving The ability to think on the
feet and providing good judgment Knowledge of Microsoft Office
(Word, Excel, PowerPoint, Outlook) Strong communication and
interpersonal skills Must have the ability to function in a
team-based manufacturing environment The ability to collaborate
with all levels of management in a multi-functional team
environment Preferred: Good technical understanding of
manufacturing equipment and processes Knowledge of product/process
risk management (pFMEA) Knowledge of statistical data analysis
tools (e.g. Minitab) Technical training and experience using
Statistics, Lean and Six Sigma Methodologies is preferred including
Measurement System Analysis, SPC, DOEs, Reliability, etc
Understanding of the NPI (New Product Introduction) process and
Process Validation expertise A thorough understanding of GMP/ISO
regulations and validation regulations Demonstrated project
management and project leadership abilities. ETQ (Documentation
Storage) for CAPA's Experience with Adaptive for Doc Control
Experience with design life cycle Design verification testing
Design review experience Process capability experience
Understanding of process scale up DFMEA experience, this goes hand
and hand with Design review. DFMEA is design failure mode analysis
Education A minimum of a bachelor's degree in engineering, Science,
or related technical fieldEqual Opportunity Statement If you are
interested, please forward your resume in MS Word format ASAP. to
pradeep.darbhe@rcmt.com. Contact: Pradeep at (908) 405-7974 RCM is
an equal opportunity employer. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability, or status as a protected veteran.DisclaimerThis
job description is intended to describe the general nature and the
level of the work being performed by the people assigned to this
position. It is not intended to include every job duty and
responsibility specific to the position. RCM reserves the right to
amend and change responsibilities to meet business and
organizational needs as necessary.
Keywords: RCM Technologies, Brockton , Quality Engineer, Engineering , Raynham, Massachusetts
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