Supplier Quality Engineer

Company: Ottobock SE & Co. KGaA
Location: Salt Lake City
Posted on: January 26, 2023

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