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Career Opportunities

Career Opportunities:

Irvine, CA
Junior Quality Engineer
Date Posted: 12/29/2015

Job Description:
Monitor day-to-day QA inspection activities. Responsible for MRB activities and associated CAPA and SCARs. Responsible for Supplier Monitoring and Evaluation, product control plans, and QA Trending. Assist defining what methods and equipment will be used to measure key quality characteristics of a process. . Provide technical assistance and training on work instructions and procedures within the QA department and assist manufacturing, purchasing and new product development teams, as needed.

    Essential Job Duties:

  • Support QA Inspection activities and support Material Review Board process of rejected materials including review, disposition and corrective/preventive action, working closely with Manufacturing and Engineering
  • Maintain reporting of company metrics and measureables, produce Company Scorecard. Coordinate Continuous Improvement with management based on data.
  • Develop/support master control plans, process control plans and inspection control plans
  • Performs/supports validation studies such as IQ,OQ,PQs and GR&Rs associated with new product/processes in manufacturing
  • Collaborates with Engineering as assigned throughout the product development cycle.
  • Maintain/support all key performance indicators (complaints, supplier data, manufacturing information) and actively participates in problem resolution and corrective/preventive actions
  • Supports supplier management through quality audits, vendor qualification, PPAP, and vendor monitoring activities (supplier scorecards)
  • Implements quality assurance practices and procedures, test plans and other QA assignments
  • Provide biweekly, monthly and annual reports, assit with design of reports and graphs
  • Perform other duties as assigned
    Accountabilities:

  • Guarantee quality of products in highly regulated environment
  • Ensure all quality aspects of this position
  • Maintain a safe working environment

For additional information please click here. If you are interested in applying please email your resume to esd.careers@pro-dex.com and indicate the position of interest in the subject line.


seperator

Irvine, CA
Quality Assurance/Regulatory Affairs Specialist
Date Posted: 12/29/2015

Job Description:
Helps ensures that the company’s products consistently meet or exceed established quality standards. Ensure that processes and work practices are documented and are efficient, effective, and compliant to local, state, federal and international regulations which pertain to medical device safety and effectiveness, worker health and safety, and environmental protection. Provide regulatory input to product development, market strategy, and business planning and resource allocation decisions to ensure full regulatory compliance with all aspects of the business. Support/execute planned facility and product development RA strategies. Responsible for day to day Quality System processes and tasks including Complaints/CAPA, Audits, Deviations and Process/Product Validations.

    Essential Job Duties:

  • Ensure that company quality standards for manufactured and repaired products are adhered to consistently.
  • Work closely with Product development teams to ensure regulatory requirements are met on all projects
  • Prepare Quality Assurance/Regulatory reports and present status in review meetings.
  • Prepare reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs.
  • Responsible for complaint and CAPA systems. Provide responses to customer complaints.
  • Perform research to determine Regulatory requirements of new markets & product requirements
  • Communicate and advise customers on Regulatory issues
  • Travel as required
  • Perform other duties as assigned
  • Perform annual internal regulatory audits and inspections and report findings to management.
  • Respond to safety inspection findings.
  • Provide safety and quality system training to employees.
  • Maintain current procedures
  • Conduct process, method and root cause analyses.
  • Prepare 510K and CE Marking submission documents and maintain records.
  • Prepare a variety of written correspondence and documents.

Skills and Qualifications:
Knowledge and complete understanding of Quality System Regulations/cGMPs and ISO 13485 Quality System Standard. EU medical device regulations a plus. Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to analyze trends and draw logical conclusions.

Must be proficient in Microsoft Word/word processing and Excel/spreadsheet as essential skills. Proficiency in Access and ERP systems a plus. Critical thinking, facilitation, negotiation skills and collaboration abilities essential.

    Accountabilities:

  • Manage and monitor the Regulatory and Safety issues and advise management on a timely basis
  • Develop new ideas and strategies to improve procedures or policies.
  • Ascertain integrity of procedures.
  • Ensure that work is being performed in accordance with documented procedures.
  • Seek to improve and make changes in procedures to document “best practices”.
  • Keep up with all regulations and stay informed of organizational changes.
  • Remain well prepared for audits by external agencies/organizations (including, but not limited to FDA, ISO, EPA, OSHA).
  • Sustain safe work environment.

For additional information please click here. If you are interested in applying please email your resume to esd.careers@pro-dex.com and indicate the position of interest in the subject line.