Quality Control Inspector

Company: Q'Apel Medical, Inc.
Location: Fremont
Posted on: November 16, 2021

Job Description:

Job DescriptionQuality Control Inspector
Job Description Summary:Primarily responsible for performing Quality Compliance and Quality System Development inspection of the manufacturing processes. The role is multifaceted and varied; it requires cross functional project management skills and the ability to influence across the organization to drive compliance activities. Provides direction as needed to the leadership team at Q'Apel Medical, LLC and oversees quality activities to assure compliance to applicable federal and state regulations, international standards, and the company's Quality Policy.
Position Responsibilities and Authorities:

• Supports productions needs as scheduled.
• Performs QC inspections to work in progress product and incoming components.
• Drive continuous system, process, and product improvements throughout the organization.
• Identify and issue NCMRs according to current procedures.
• Assure that the company's QMS is compliant with current FDA QSR, ISO 13485:2016, MDD and other standards as applicable.
• Inspect, test and review documentation to release product to Q'Apel's customers.
• Develop and review policies and procedures to ensure that the appropriate checks and balances are included to ensure a quality output.
• Perform and assign responsibilities within QC to ensure company objectives are achieved in a timely manner.
• Define and support the Q'Apel's Quality Policy and Quality System.
• Other duties as assigned.
  QualificationsExperience & Skills:
  • 2+ years minimum experience working in a regulated industry (medical device development experience preferred along with a solid working knowledge of FDA Quality System Regulations and ISO 13485).
  • Must have experience with inspecting incoming components with manual tools such as: multimeters, pin gauges, snap gauges.
  • Experience working in a controlled environment room (CER).
  • Good manual dexterity and visual acuity.
  • Strong interpersonal skills.
  • Effective communication skills (both written and verbal) required.
  • Experience in a small company environment is a plus.
  • Knowledge and exposure to applicable regulations (QSR, MDD, CMDR, and ISO).
  • Ability to work independently or in a team setting.
  • Works well under pressure, organized and self-motivated.
  • Strategic Thinking, negotiating, decision making ability, and analytical skills
  • Ability to make rapid decisions
  • Diversified background with exceptional technical and managerial skills
    --- Additional InformationAll your information will be kept confidential according to EEO guidelines.

Keywords: Q'Apel Medical, Inc., Fremont , Quality Control Inspector, Other , Fremont, California