The Quality Manager, Acquisition is responsible for strategic oversight and leadership direction within the assigned Production Business Unit to include: In-Process Inspection, Finshed Good Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigations (internal and external), Supplier Quality, and Calibration.
- Oversees the plant internal auditing function to assure compliance with all company and division guidelines and government and regulatory requirements.
- Directs resources in the performance of audits of Quality Assurance/Manufacturing documentation and systems for compliance with, ISO 13485 and ISO 14971, including the development and maintenance of policies and procedures and publishing of effective and objective auditreports, coordination and review of audit responses and subsequent verification of corrective and preventive actions.
- Oversees the plant Corrective Action Preventive Action program, assuring actions are completed in a timely manner.
- Responsible for the maintenance and reporting of local and division metrics to management.
- Coordinates the management of the electronic documentation system (ECoMs) to ensure that documentation is maintained and available at points of use throughout the site, as well as the administration of the Engineering Change Order (ECO) system to assure procedures and specifications comply with pertinent Corporate, Division and regulatory agencies.
- Responsible for assuring compliance with all applicable federal, state, local, regulatory and company requirements.
- Supports continual improvement efforts in regards to documentation collection, retention and incorporation into Devise History Records and process documentation for product lines.
- Also responsible for the maintenance and reporting of local DHR metrics to management.
- Utilizes and directs Six-sigma improvement projects in continuous improvement of processes and overall departmental performance in meeting departmental and division goals and metrics.
- Responsible for the document retention area and management of entry and disposal of stored documents.
- The Quality Manager, Acquisition is responsible for strategic oversight and leadership direction within the assigned Production Business Unit to include: In-Process Inspection, Finshed Good Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigations (internal and external), Supplier Quality, and Calibration.
- The Quality Manager shall maintain full compliance with FDA Quality System Regulations (21 CFR Part 820) as well as all applicable International Standards (i.e. ISO 13485, GMPs, etc.) and BD Policies and Procedures.
- Bachelor of Science degree in Engineering or Science related field
- Minimum 7 years experience in quality, with a minimum of 3 years in the medical device industry
- Minimum 2 years management experience
- Experience with SAPpreferred
- Experience in Lean/Six Sigmapreferred
- ASQ CQA, CQE, CMQ/OE preferred
- Computer proficiency in Microsoft Office (Word, Excel, Power Point, Outlook)
Job ID R-312363