Supplier Quality Specialist, Device Management- Any L-HSP or PFZ loc. - Hospira - Lake Forest, IL

Supplier Quality Specialist, Device Management- Any L-HSP or PFZ loc. - Hospira - Lake Forest, IL -

Supplier Quality Assurance is liable for offering the useful and strategic management vital to make sure that all Suppliers meet the very best Hospira and International requirements. The target of this division is to steer the event, implementation and upkeep of Relationship Administration for our Medical Device Suppliers. The division is answerable for offering the management for progressive and steady high quality enchancment processes that promote buyer satisfaction and repair whereas sustaining regulatory compliance. The division drives high quality enchancment and improvement actions with Exterior Suppliers, and companions with HSP Manufacturing Websites, International Supplier Auditing, Procurement, R&D and PMO organizations. This place works with all useful areas to make sure that all Hospira Quality Methods and compliance requirements are achieved to allow our Suppliers in offering high quality merchandise and elements world-vast. This place is chargeable for scheduling provider audits in addition to planning, execution, monitoring, and completion of provider audits for suppliers utilized by Hospira globally. By way of audit execution, the place manages the evaluation and identification of potential provider points and danger whereas speaking provider audit evaluation info to procurement, website management, and program management. This perform assesses the provider’s functionality of assembly manufacturing requirements. The varied requirements might embrace ISO, FDA, cGMP, EU, PIC/S, and so on.

Scheduling provider audits, sustaining correct info and updates to the provider schedule, and monitoring and reporting metrics related to completion and execution of audit actions for Device Suppliers.

Performing provider audits towards applicable international requirement per an permitted audit schedule and revisions together with performing the next basic actions:

• Audit preparation and agenda communication


• Scheduling audits with suppliers


• Audit report creation and finalization


• Issuing accredited audit reviews to provider


• Managing marketing consultant execution of provider audits (the place relevant), evaluating audit outcomes and performing comply with-up actions, as applicable.


• Reviewing and approving provider audit motion plans (CAPA Plans)

Finishing closure of audits, when no audit observations or minor solely observations are recognized

Documenting a press release of general compliance for audited provider websites

Monitoring and speaking relevant auditing exercise metrics (resembling report completion, timeliness, provider audit CAPA plan timeliness)

Supervise Supplier Auditors and/or contract staff.

Liaise with Techniques and Operations group, international auditors, and suppliers to satisfy enterprise aims and objectives.

Help provider improvement actions for system suppliers.

Expertise/Expertise Schooling/Certification

Bachelor’s Diploma in Life Sciences, Engineering or different associated Technical/Scientific Space of Enterprise Administration

A minimal of 6- 10 years of expertise.

A primary understanding of working with contractual/authorized phrases and circumstances is most popular; nevertheless the Supplier Quality Affiliate should have the ability to learn, perceive, and interpret provider high quality agreements and write amendments or extensions to these contracts, requiring a excessive diploma of written communication skils.

Information of worldwide cGMP laws; 21 CFR Elements 210, 211 and 820, ICH* IPEC Tips, and ISO Requirements (ISO 9001, 13485).

Superior information of Quality methods, management Techniques, and drawback fixing methodology (5 Whys, DMAIC, and so forth.).

Expertise with exterior suppliers and/or different events.

Want direct expertise in provider and/or inner auditing

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