Senior Engineer, Supplier Quality

Location: Keene, NH (03435)
Company: Icu Medical Inc.
Industry: IT
Job Type: Full Time
Posted: 5 days ago
Job Description
Our Senior Engineer, Supplier Quality is responsible for providing the functional and strategic leadership necessary to ensure that all Suppliers and Third Party Manufacturers (TPM) meet the highest ICU Medical and Global standards. The objective of this position is to lead the development, implementation, and maintenance of Relationship Management for our Suppliers and TPM.

This position provides Quality consulting to Suppliers, TPMs of finished products, Regional Sites, TPM Operations, Commercial Quality, Marketing, Supply Chain, R&D and PMO organizations. This position works with all applicable functional areas to ensure that Purchasing Controls requirements and compliance standards are achieved to enable our Suppliers and TPMs in providing safe and compliant products worldwide. DUTIES & RESPONSIBILITIES.

Develops and maintains strong partnerships with external suppliers and TPM acts as a facilitator and communicator between the supplier's Quality unit and ICU Medical Manufacturing operations and functions Support the selection and development of new suppliers and TPM based on their QMS and Operations capability and assure that product launches and initiatives are met. Owns suppliers and TPM qualification processes. Assure existing suppliers and TPM meet ICU Medical expectations and standards.

Supports, review and approve documentation which may include Audit reports, Quality Agreements, Validation reports, Supplier CAR and/or Investigations Serves as the Quality lead on product support teams for assigned Suppliers and TPMs. Ensures that all Quality attributes are met, and qualification packages are completed and approved before product is purchased and/or finished goods are released to market. Works with cross-functional teams to complete assessment of suppliers and TPMs Partners with Global Procurement and R&D to identify the supplier base per the QMS, also cooperatively and continuously improve supplier Quality relationships Takes leadership in maintaining the Suppliers and/or TPM Quality Program.

Partners with and provides global support to the ICU Medical Manufacturing sites and regional headquarters including EMEA, Latin America, Canada, Australia/New Zealand and Asia-Japan regions. Identifies any system weakness and establishes improvement plans Collects data of Suppliers and TPMs under ICU Medical responsibility, and prepares high level summaries of the Quality issues, commercial impact and applicable supplier and TPM metrics, to all levels of the organization that require it Supports suppliers and TPM investigations to identification of true root cause, technically sound conclusion and timely closure Assure that proposed Supplier and/or TPM changes that impact ICU Medical products/processes or supply base are approved and compliant to existing QMS procedures Represents ICU Medical Quality Management, when applicable, during discussions/communications of serious issues including stock-outs, potential recalls or non-compliance to product specifications and regulatory deficiencies. Delivers communications tailored to the needs of the audience (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.

Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus Supports Supplier and TPM audits by providing key Supplier and TPM product information to auditors including latest on-market trends and events, key operational issues and potential non-compliance issues for investigation Monitors Quality data sources to identify trends and to hold TPMs accountable to promised metrics. Analyzes and presents data to TPM management and ICU Medical management This position is responsible for maintaining assigned Supplier and TPM files and records. DIVERSITY ICU Medical is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. THE INDIVIDUAL. Bachelor's degree in Science or Engineering from an accredited college or university is required; Master's Degree is preferred Minimum of 7 years experience is required Demonstrated experience in Supplier and/or Third Party Manufacturer relationship management and development Cross functional relationship management and interpersonal skills, impacting global markets. Demonstrated skill in data analysis, presentation, and project planning and execution Demonstrated success in managing suppliers, contract manufacturers, over a broad geographic area Demonstrated ability to develop new concepts or methods that break new ground in order to support overall Quality performance improvements of the supply chain ASQ Certified Quality Auditor, Certified Quality Engineer, Certified CQM/OE, Six Sigma Green Belt, Black Belt, or equivalent is desired.

SALARY & BENEFITS In addition to a competitive compensation package, ICU Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more!.

Web Reference : AJF/367446000-202
Posted Date : Wed, 28 Sep 2022

Please note, to apply for this position you will complete an application form on another website provided by or on behalf of Icu Medical Inc.. Any external website and application process is not under the control or responsibility of IT JobServe

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