Quality Specialist – Medical Devices (Sylmar, CA)

  • Job Details

  • Job Status: Filled
  • Posted On: August 17, 2017
  • Job Category: Engineering
  • Position Type: Full Time
  • Location: Sylmar, CA
  • Desired Experience: 3+ years
  • Desired Education: Technical Associates degree, minimum
  • Compensation:
  • Travel: No
  • Relocation: No

We have a client looking to hire an experienced Quality Specialist.   

The Location:  The position will be located in Sylmar, CA and reports to the Director of Operations.

The Position: 

The Quality Specialist is responsible for collecting and maintaining all documents necessary to define product configuration and control of manufacturing processes and company procedures that insure compliance to FDA, and ISO regulations; develop and maintain a comprehensive filing system and computer database for all documents to be retained and controlled; and develop and monitor the company training database and ensure that all users have access to the latest revision of the appropriate documentation in a timely manner.

 

Responsibilities:

  • Execute the company’s document control process and assure conformance to GMP and company standard documentation practice.
  • Create, update, review, and release Standard Operating Procedures, Specifications, Protocols, Work Instructions and Forms.
  • Coordinate storage, archiving, and retrieval of documents and quality system records.
  • Contribute to maintaining Device Master Records (DMR), Device History Records (DHR), and Production Files.
  • Maintain CAPA and Complaint records and tracking systems.
  • Process Change Control Documentation.
  • Generate Non-Conforming Material Report (NCMR) when materials are observed defective and conduct proper containment.
  • Create, update and route for approval documentation as directed by the Change Control Process.
  • May assist in performing audits and responding to third party audits as required.
  • Sample and inspect raw materials, sub-assemblies and final products to approve specifications for conformance. Inspection processes are identified as receiving, in-process, and final inspections.
  • May assist in conducting product inspections and engineering studies associated with a qualification/validation.
  • As required generate inspection records and verify information for accuracy.
  • Ensure that documents and records meet company’s good documentation practices.
  • Support Quality Department in developing and optimizing systems/processes that are aligned with the overall business strategies.

Requirements: 

  • Technical Education or Training equivalent to an Associate Degree or Bachelor Degree
  • Preferred knowledge of FDA Quality System Regulation, ISO 13485, ISO 9001, 21 CFR 820 and how they impact Document Control activities.
  • Understanding of machining and assembly operations
  • Experience using electronic Quality Management Systems (eQMS, such as uniPoint, MasterControl, or similar)
  • Ability to read blueprints
  • Knowledge of standard inspection and test equipment (e.g. Calipers, Micrometers, Height gage)
  • Understanding of Quality Methods
  • Lean Six Sigma Green Belt Training
  • Accurately communicate ideas, facts and technical information, both written and verbal
  • Detail oriented, self-auditing and have high quality standards.
  • Follow safety and security practices and maintain confidentiality of information.
  • Able to assist in technical writing according to organizational standards regarding order, style, terminology and format.
  • Detailed technical experience applicable to standard Document and Data control activities in a Quality System regulated environment.
  • Working knowledge of Microsoft Office programs and the ability to use personal computers to operate company systems e.g. MS Word, Excel, Power Point, QMS software.
  • Ability to read and write in English; secondary language skills are desirable but not required.
  • ASQ member is desirable but not required.

 

The Compensation:  Compensation is commensurate with experience.  The company also provides excellent benefits, has a matching 401K plan, a quarterly bonus program and growth opportunities.

 

** Candidate must be a US citizen or green card holder **

Preference for local candidates or someone who has ties to the area

Offer is contingent on successful passing of background check and drug testing

 

 

If you, or someone you know, may be interested and qualified for this position, please forward your resume and letter of interest

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