Quality Control Inspector III

Therapy Device (IGTD) customers following established inspection procedures.

- This individual will have customer interaction with Quality Management, Customer Service, Planning, Logistics and Philips Contract Manufacturing.

- This individual will be required to develop, create, and implement inspection procedures, document non-conformance reports and final product release documentation.

- This individual will be responsible for assuring that finished products meet all final acceptance criteria as specified by procedures and that all Device History Record documentation is correct and complete in accordance with Quality Data Recording Requirements, and provide metrics and analysis as needed.

- This person must effectively communicate inspection and investigation results both written and oral cross-functionally to Philips personnel.

- This individual will conduct, and document audits of the Philips Image Guided Therapy (IGT) quality system as required. The Inspector notifies management and/or other required functions of findings that are not meeting requirements from verification and/or usage decision.

- Ensure that quality inspection activities are conducted documented and communicated in accordance with GMPs, FDA (Food and Drug Administration (USA), ISO (International Standard Organization) Requirements and Company Operating Procedures.

- This position contributes to the companys quality objectives in accordance with the established Quality System and Policy.

DUTIES AND RESPONSIBILITIES:

- Coordinate workload with other inspectors and provide guidance within the team when needed

- Review relevant documents for updating when necessary and provide suggestions for improvement

- .Update relevant work instructions as necessary

- Assist with Client and CAPA activities as needed

- On-going development and objective analysis; documents the results of inspections and dispositions of finished product for distribution to Philips Volcano Customers.

- Inspections of Finish Good materials, kits, and sub-assemblies to specifications and requirements, and execute release in ERP System

- Conducts in-process product and process inspections and audits as required

- Initiates and documents investigations of finished product non-conformances

- Initiate Non-conforming material report as necessary and segregate materials appropriately

- Disposition of non-conforming materials based on MRB decision as necessary

- As self-directed, determine and document the appropriate disposition status of customer returned products (e.g. Excess, Obsolete) to its next destination (e.g. Scrap, Rework, Restock, RTV). Trend finished product inspection results including results from sterilization reports from third party laboratory. Based on independent judgment, take appropriate actions based on alert limit excursions.

- Actively participates on the cross functional Finished Device Material Review Board as the QFI representative.

- Perform all work in compliance with company SOPs, WIs and regulatory and safety standards.

- Collaborate with other internal groups for inspection related inquiries and issues

- Perform other related duties as assigned.

- Detail oriented in reviewing device history records with a critical eye to documentation completeness and correctness based on established procedures

- On-going development and objective analysis; documents the results of inspections and disposition of finished products for distribution to Philips Customers.

- Conducts in-process product and process inspections and audits as required

- Inspections of Finish Goods, Kits, and Sub-assemblies to specifications requirements, execute release in ERP System.

- Initiates and document investigations of finished product non-conformances

- As self-directed, determine and document the appropriate disposition status of customer returned products (e.g. Excess, Obsolete) to its next destination (e.g. Scrap, Rework, Restock).Trend finished product inspection results including results from sterilization reports from third party laboratory. Based on independent judgment, take appropriate actions based on alert limit excursions.

- Actively participates on the cross functional Finished Device Material Review Board as the QFI representative.

- Conduct and document process and system audits using written procedures as audit standards

- Initiate NCMR reports on nonconforming material as necessary and segregate materials appropriately

- Disposition of non-conforming materials based on MRB decision.

- Accurately document the results of inspections and testing

- Maintain all controlled document records in a timely and accurate manner

- Participate in the construction and/or revision of SOPs/WIs for Final inspection function

- Assist in writing and updating inspection procedures, protocols, and checklists

- Evaluate problems and make initial recommendations for possible corrective action to Supervisor

- Use computer for obtaining and data entering information

- Provide support to Manufacturing when required

- Manage quarantine inventory

- Capable of lifting 30lbs

You are a part of

- Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery.

- The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.

To succeed in this role, you should have the following skills and experience

- Requires 2-5 years of Quality experience in Pharmaceutical, Biopharmaceutical, or Medical Device Industry with product visual and functional inspection duties; or an equivalent combination of education and experience

- AA degree or higher in Science, Business or Engineering discipline, bachelors degree preferred.

- Experienced in reviewing device history records with a critical eye to documentation completeness and correctness based on established procedures. As self-directed, take appropriate action relative to issue management (i.e. Initiate non-conformance reports and CAPAs as appropriate)Strong analytical skills with a working knowledge of statistical methods (e.g. SPC).Experienced with Risk Management procedures and Failure Modes and Effects (FMEA) analysis.

- Experienced in writing inspection reports and presenting results to management as required.

- Ability to work effectively both orally and in writing in a highly matrixed organization and communicate with third-party inspection services relative to inspection results.

- Demonstrated understanding and working knowledge of FDA Good Manufacturing Practices (GMP) and ISO13485Experienced in the use of sampling plans

- Computer literacy is required. Must be able to follow documented SOP and standards, as well as have knowledge of ISO Quality Standards (21 CFR 820 & ISO 13485)DESIRABLE QUALIFICATIONS: Basic understanding of 21 CFR 820 an asset

- Exposure to Good Manufacturing Practices (GMP) an asset

- Works well in a matrixed managed organization.

- Familiar with a variety of the field's concepts, practices, and procedures

- A certain degree of creativity and latitude is required.

OTHER PARTICULARS:

- Clear and effective oral and written communication skills

- Strong attention to detail and follow up skills

- Strong organizational office skills

- Ability to handle multiple priorities with tight deadlines

- Proficient in MS Office, other computer programs an asset

Requisition Start Date: 2024-01-29

Requisition End Date: 2025-01-28

ORU: Philips Image Guided Therapy Corp (US9H)

Site: CA-2451 Mercantile-Rancho Cordova

Location: CA-2451 Mercantile-Rancho Cordova