Quality Control Engineer - Healthcare

Plastikon Healthcare is looking for a Quality Control Engineer to provide and directs activities with development, application, technical support and maintenance of quality standards for all value-adding industrial processes, materials, or products. Position requires an independent thinker who has extensive analytical capabilities with respect to root cause identification, correction and prevention of issues.

RESPONSIBILITIES:

• Acquires information from customers and suppliers and communicates it internally to ensure that customer specifications and expectations are met or exceed
• Develops and initiates standards and methods for inspection, testing and evaluation
• Provides technical support to manufacturing functions, product and inspection issues
• Interfaces with production, tooling and engineering to determine root cause of quality issues, action plan for correction and implementation
• Develops and implements methods and appropriate use of SPC
• Writes, revises and verifies quality standards and procedures for inspection
• Identifies differences between established standards and user applications and suggests modifications to conform to standards and cGMP.
• Monitors program performance after implementation to prevent recurrence of program operation problems and ensure efficiency of operations
• Devises sampling procedures and designs and develops forms and instruction for recording, evaluating, and reporting quality and reliability data
• Supports various functions in implementation of processes/systems to meet various ISO requirements: ISO 9001 and ISO 13485
• Participates in cross functional opportunities to develop DFMEA’s, PFMEA’s and control plans
• Ensures identified controls are implemented within production and quality functions
• Facilitates corrective action and validate effectiveness of implementation
• Participates as a member of task forces to implement projects supporting production and training
• Compiles and writes training material and conducts training sessions on quality control activities
• Designs and facilitates process capability, reproduce ability and engineering change to products

REQUIREMENTS:

• Bachelor’s degree in Industrial, Mechanical, Electrical, or Manufacturing Engineering
• 3+ years’ experience in a GMP (medical devices or healthcare) manufacturing environment.
• Ability to work flexible hours including weekends to support production
• Ability to work in a fast-paced and deadline-driven environment
• Proficient in SmartSheet and Microsoft Office tools: Outlook, Excel, Word and PowerPoint.
• Knowledge of production/engineering of injection molded plastic, statistical process control techniques and application, and design failure analysis
• Familiar with blueprints
• Experience and knowledge of ISO standards
• Working knowledge of surface plate calibration techniques, various inspection tool gauges, optical CMM, electronic test equipment
• Knowledge of mathematical functions is essential

Job Type: Full-time

Pay: $95,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Weekend availability

Application Question(s):

• All California applicants for employment must provide evidence that they have received a COVID-19 vaccination that has been authorized by the Food and Drug Administration for use in the United States and are fully vaccinated, unless you can provide a medical or religious reason for the exemption. If you received the Pfizer or Moderna vaccination, proof of receipt of both doses is required. Receipt of one dose of the Johnson and Johnson vaccine is also acceptable. Fully vaccinated means it has been 14 days after the second dose of the Pfizer or Moderna vaccine has been given or it has been 14 days after the one dose of the J&J vaccine has been given. Are you fully vaccinated?
• Will you now or in the future require sponsorship for employment visa status (e.g. H-1B visa status)?
• What are your salary expectations?

Experience:

• Quality Control: 3 years (Required)
• manufacturing: 2 years (Required)
• GMP: 2 years (Required)

Work Location: One location

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