Supplier Quality Engineer
Company: Ottobock SE & Co. KGaA
Location: Salt Lake City
Posted on: January 26, 2023
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Job Description:
For more than a century Ottobock has pursued the mission of
helping people living with limb loss or mobility challenges regain
or maintain their freedom of movement. We do this through the
development of leading prosthetic, orthotic and wheelchair
innovation and an unwavering commitment to delivering superior
patient care experiences. As a growing healthcare company, we
continue to invest in both our people and new service offerings.
With more than 8,000 employees worldwide and 1,100 across North
America, we are dedicated to advancing the O&P industry and
improving the lives of the people served by it.The incumbent is
primarily responsible to ensure a Suppliers are appropriately
categorized, qualified, monitored continuously and continue to meet
the requirements set forth by Ottobock's product specifications and
QMS. Provide Support for Quality Systems Audits, CCB, MRB, and
other systems that interface with the Supplier Management System
within the QMS.
Support other departments in implementing and improving a compliant
Quality System.Responsibilities:--- Establish/refine supplier
agreements and requisites to meet current ISO & FDA
requirements.
--- Assist with creation and modification of Quality System
procedures, work instructions and related documentation.
--- Assist in qualifying and vetting new suppliers to meet Ottobock
quality and regulatory requirements.
--- Help establish and monitor supplier performance metrics
surrounding quality.
--- Assist in documentation, communication and required action for
instances of supplier related non-conformities, including NCR's and
SCAR's.
--- Monitor and report on Quality Management System metrics related
to Supplier Controls
?--- Perform supplier audits as appropriate.
--- Contribute to risk assessment analysis for purchased component
substitutions or replacements.
--- Support Product Development with the classification of critical
components and maintain this list for all products
--- Assist in ISO and FDA audit preparation, execution by serving
in the capacity as the subject matter expert.
--- Perform complex investigations and coordinate w/ technical
teams to ensure sound experimental design, effective data analysis,
identification, implementation, verification and validation of
Supplier Corrective Actions and subsequent closure of
investigations related to supplier defects
--- Support and participate in cross-functional projects when
assigned/appropriate.
Provides front line support for 3rd Party Inspections and Audits
(e.g. Registrar, Notified Body, FDA, or customer audits).
Ensure facility and product compliance to ISO 13485, 14971, and FDA
standardsParticipate on Material Review Boards (MRB) and Change
Control Boards (CCB) when necessary to address risk issues related
to Supplier Controls.
Works on complex investigations and coordinates technical teams to
ensure sound experimental design, effective data analysis,
identification, implementation, verification and validation of
CAPA, and subsequent closure of investigations.
Model the Otto Bock Vision and Code of Conduct consistently in
word, attitude, and actions.
Other duties as assigned.Qualifications:Bachelor's Degree in Math,
Science, Business, Engineering, or other scientific based
discipline - or equivalent work experience.
2+ years in Quality Engineering experience, or 4+ years Quality
Systems or Quality Assurance work experience is required.
Minimum of 2+ years' experience in an FDA regulated industry
(medical device, pharmaceutical, etc.) is required
License (s):
American Society for Quality (ASQ) CQE, CQA, CMQ/OE, or equivalent
professional credential desired.Excellent Team Player; Liaison;
Coordinator
Strong Leadership and Decision Making skills
Keywords: Ottobock SE & Co. KGaA, Salt Lake City , Supplier Quality Engineer, Engineering , Salt Lake City, Utah
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