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Cordis Lead Operator - Prod Ops (2nd Shift) in Santa Clara, California

Description

Essential Duties and Responsibilities:

  • Adheres to all Quality Policies and Systems of the Company. Is a proponent for them and helps enforce them on the Production floor.

  • Maintains accurate records, including Lot History Records (LHRs) and adheres to all GMP/GDP policies

  • Must be able to process small parts under a microscope (as needed)

  • Consistently meets or exceeds the average cycle time and quality standard requirements for the stations/processes trained/certified to. Is able to adequately fill in for operators as needed.

  • Maintains an acceptable level of attendance (including scheduled overtime)

  • Trains and possesses a detailed understanding of all processes in their area of responsibility. Is considered an Subject Matter Expert (SME)

  • Flexes and rotates to other stations as needed or assigned

  • Helps to ensure that the team is consistently maintaining accurate records and is following all GDP/GMP requirements.

  • Serves as a role model for ensuring Quality System Regulations adherence

  • Helps analyze production metrics to suggest improvements for inefficiencies on the Production floor and drives the line to maximize production output without sacrificing high quality standards

  • Coordinates all Engineering Build Requests (EBRs) and Rework activities (training, execution of tasks, and documentation review) as required

  • Advises the Production team with limited direction from the Production Supervisor

  • Can effectively fill in for the Production Supervisor when not available; in this role, responsible for training others, managing the Production floor activities (as needed), performing LHR reviews, performing limited troubleshooting activities, and notifying engineering/maintenance of issues

  • Works with Engineering staff to develop new processes, provide feedback for the creation of new documentation (i.e. MPIs, SOPs, etc.) and train others to these documents (as needed)

  • Consistently identifies improvement opportunities by performing Gemba walks

  • Recommends and initiates actions to prevent the occurrence or reoccurrence of product non-conformances and assists in the implementation and verification of solutions

  • Performs other duties as required.

Education and Experience Requirements:

  • High school diploma or equivalent and 7+ years experience in the medical device/pharmaceutical field or in a related area

  • Must be able to work in a Controlled Environment

  • Must have excellent good hand‐eye coordination

  • Demonstrates advanced reading comprehension, writing, and math skills

  • Must be detail oriented and demonstrate a high level of inventory control skills (with respect to the math and accountability parts)

  • Must be able to accurately verify others’ work for accuracy(i.e. work content, actual part counts, LHR documentation)

  • Must be able to work with cross‐functional groups to resolve any discrepancies/documentation errors

  • Prior experience in Polymer processing (min. 3 yr) or prior experience (min. 5 years) in catheter assembly processing (including sub‐assembly processes and tipping processes) is a plus

  • Must have intermediate to advanced computer skills (i.e. Microsoft Excel, Word, Power Point, QAD)

Qualifications

Education

Required

  • High School or better

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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