Manufacturing Engineer
Company: Kelly Scientific Resources
Location: Memphis
Posted on: January 12, 2021
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Job Description:
VIRTUAL OPPORTUNITY!!! Work from home as an--EU
MDR--Manufacturing Engineer.The EU MDR Manufacturing Engineer will
perform review/remediation Design Control activities involved in
the technical filing of product, under supervision of the EU MDR
Engineering Systems Manager. This position will support the EU MDR
department by performing tasks that will assure the timely delivery
of the documentation, working with cross functional departments.
This role will be responsible for the delivery of tasks to ensure
conformance to the project plan schedule and for ensuring efficient
and effective communication of affected technical file documents
for manufacturing to support EU MDR submissions. The SCOPE covers
product in the Orthopedics groups. This covers all manufacturing
sites (including 3rd parties) and must be implemented in line with
the relevant MDR timelines in order to continue to sell product in
Europe. All projects are to be managed using local design control,
and change control procedures. The solution is also subject to
audit by notified bodies. Principal Accountabilities (Major end
results the job is expected to achieve)* To take ownership of the
manufacturing engineering tech document process, ensure it is
adhered to and applied effectively, correctly and efficiently*
Effectively manage 3rd party suppliers (with support of Procurement
and Supplier Quality) to deliver expected outcomes (50+ 3rd parties
in 5 continents)* To deliver the deliverables for MDR Manufacturing
prior to MDR timelines associated with the project* To take
responsibility that change control procedures are followed and that
the quality of the work is acceptable to internal and external
auditors eg group audit, BSI and FDA Job Context / Key Challenges*
Strong communication skills including technical writing, listening
and speaking; ability to influence others communicate effectively
with multi-functional teams (internal and external) that assists
with driving project completion.* High learning agility with the
ability to analyse and synthesize data and then present it to
senior leaders* Independent thinking and the ability to work within
a team is required* Ability to assess technical issues and develop
solutions utilizing an analytical approach to problem solving*
Ability to resolve conflict in a matrix environment is a key
requirement of the role.* Establish and maintain effective
relationships with third party suppliers and internal departments
to ensure effective implementation of project delivery.* To
maintain and develop in-depth knowledge of the EU MDR document
compliance requirements and act as the Manufacturing process expert
for the subject.* Documentation to a standard that will be accepted
by internal and external auditors.* To apply and promote high
standards of Occupational Health, Safety and Environmental
Compliance in accordance with the Company HSE policy and
processes.* To comply with the Ethics and Compliance Code of
Conduct in all matters Knowledge and Experience (Knowledge and
experience needed for satisfactory--performance of the job)* A
science or engineering based degree, or relevant industry
experience* Experience of project management within a relevant
industry.* Experience/knowledge of various Manufacturing processes
related to Orthopedic devices.* Proven track record of delivery.*
Knowledge of Verification and Validation activities, PFMEAs, Macro
Processing Maps, Detailed Processing Maps.* Self- starter, with the
ability to work independently* Software programs - Microsoft Word,
PowerPoint, Excel, and MS Project.* Knowledge of applicable
specification and regulations standards.* Knowledge and
understanding of documentation/quality/regulatory processes.*
Knowledge of change control processesWhy Kelly--?Kelly-- Science &
Clinical is your connection to premier scientific and clinical
companies looking to hire talented people just like you. Every day,
we match science professionals with dream jobs that fit their
skills and interests-it's the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/non-traditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce and providing accommodations for people with disabilities
in all parts of the hiring process as required under its Employment
Accommodation Policy. Kelly will work with applicants to meet
accommodation needs that are made known to Kelly in advance.
Keywords: Kelly Scientific Resources, Memphis , Manufacturing Engineer, Other , Memphis, Tennessee
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