Lot Release Inspector

Dexcom, Inc. Mesa , AZ 85205

Posted 2 months ago

Performs necessary duties to evaluate assemblies and finished products to ensure conformance to drawing requirements, specifications and approved procedures. This position is responsible for ensuring that good manufacturing practices and good documentation practices are maintained in manufacturing, the coordination of the non-conforming materials process, and the review of electronic and paper Lot History Records.

Essential Duties and Responsibilities:

  • Performing in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GMP) for commercial and clinical product in a timely matter.

  • Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task.

  • Ensure all documentation is legible, complete and correct per current Good Manufacturing Practices (GMP).

  • Inspect labeling for the finished product.

  • Understand and perform line clearance activities in manufacturing.

  • Perform in-process quality audits in manufacturing to assure compliance to manufacturing documentation and good documentation practices.

  • Assist with the NCMR process during manufacturing of commercial and clinical product.

  • Demonstrate good computer skills and perform computer operations to generate reports and graphs using Microsoft Word and Excel.

  • Perform in-process product inspection and testing for commercial and clinical product.

  • Must be able to distinguish between certain colors and pass an annual color vision test

  • Familiarize yourself with the manufacturing processes.

  • Review shipping documentation to assure accurate order shipment.

  • Works closely with Research & Development, Regulatory Affairs, Clinical, and Manufacturing groups.

  • Provide training for new employees

  • Takes on new challenges and expanding roles to assist with growing demands within different areas of the Quality Department.

  • Must have strong organization skills and attention to detail

  • Assumes and performs other duties as assigned.

Required Qualifications:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Ideally has past experience working with the following; Agile, Oracle and/or Camstar software programs.

Education Requirements:

  • High school diploma or general education degree (GED)
  • Minimum of 2 year experience in a quality assurance/quality control regulated environment; or equivalent combination of education, experience and/or training.

Travel Required:

  • 0 24%

Language Skills:
Must be able to communicate effectively in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. to over 100 lbs.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be exposed to the following environmental conditions: Wet or humid conditions, work near moving parts, work in high - precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme heat (non-weather), extreme cold (non-weather), risk of electric shock, work with explosives, risk of radiation, vibration. The noise level in this work environment can range from quiet to very loud.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.

An 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.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Receiving Inspector III (15754)

MD Helicopters Inc

Posted 2 days ago

VIEW JOBS 1/15/2019 12:00:00 AM 2019-04-15T00:00 SUMMARY Inspects purchased parts and materials for conformity to Purchase Order requirements, blueprints, standards, specifications, and processing requirements. Dimensional inspection requires the use of measuring devices such as micrometers, gauges, and calipers. Interdepartmental and supplier interfaces for problem solving DUTIES AND RESPONSIBILITIES include the following. * Visual inspection for part marking, and defects or damage such as corrosion, cracks, dents, scratches, and pits and workmanship issues. * Simple dimensional inspections using calipers, micrometers etc. as defined by inspection plans. * Complex dimensional inspections that may involve compound angles or three-dimensional projections using height gages and other surface plate techniques, optical comparators or CMM inspection. * Verification of supplier paperwork including Certificate of Conformance (CoC's), material, processing and inspection documents for compliance to specifications and approved supplier list. * Making pass/fail decisions on inspected goods. * Maintaining records of results * Identify the need for corrective action for Quality Engineering review. * Perform internal audits and external source inspections. SUPERVISORY RESPONSIBILITIES None Qualifications SKILLS AND ABILITIES * Experience with FAA regulations is preferred. * Experience with DCMA regulations is preferred. * Familiar with Microsoft Office Suite to include Word, Excel, PowerPoint, Access. * Ability to solve practical problems in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. * Access to Export Control Information Required.The ability to understand and follow instructions and the ability to concentrate is required * Excellent written, verbal, communication and interpersonal skills. * The ability to get along with others or to be part of a team. * Regular attendance at the worksite. EDUCATION and/or EXPERIENCE * This job requires a minimum of High School Diploma and 4-6 years related experience and/or training; or equivalent combination of education and experience. * This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. * FAA regulations. * AS9100 Quality Management systems. * First Article Inspections. This document does not create an employment contracts, implied or otherwise, other than an "at will" relationship. CERTIFICATES, LICENSES, REGISTRATIONS None WORK ENVIRONMENT/PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Exposure to shop environment such as noise, dust, odors and fumes. * Occasionally required to lift up to 20 lbs. * Regularly required to sit, stand, bend, reach and move about facilities. * The performance of this position will require exposure to the manufacturing areas where under certain areas require the use of personal protective equipment such as safety glasses or goggles and mandatory hearing protection. * Primary environment is a warehouse environment. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. MD Helicopters, Inc. is an equal employment employer and is committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. Return to Job Opportunities MD Helicopters Inc Mesa AZ

Lot Release Inspector

Dexcom, Inc.