JunoPacific
  • 30-Mar-2017 to 31-Aug-2017 (EST)
  • JunoPacific, Redwood City CA
  • 94063, CA, USA
  • Salary
  • Full Time

JunoPacific combines the full resources of facilities located in key medical device markets in Minneapolis/St. Paul and the Silicon Valley, focusing on medical molding and assembly. Services range from tooling, part design and prototyping to micro/close tolerance molding, single and true multi-shot injection molding, vertical molding, reel-to-reel, insert molding, complex tooling that includes Spin-stack and rotary platen, multi-component/multi-material product assembly, secondary operations and validated sterile packaging.

 

Position Summary

Working manager position to maintain and improve the organization's quality management program. Manage development and implementation of systems, procedures, methods and metrics throughout the organization. Lead and develop quality assurance staff, working in partnership with sales, engineering, and operations.

Essential Job Functions

  • Maintain ISO 9001 qualification and work with our team.
  • Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause corrective action
  • Manage and work nonconforming material and CAPA process
  • Maintain and work preventive quality engineering techniques (PFMEA, SPC, Gage R&R, DOE)
  • Manage quality inspection equipment including CMM programming, GD&T, fixture design and inspection methods
  • Manage supplier certification from selection through auditing
  • Manage Internal Audit process

 Minimum Experience & Education

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

Technical Skill Requirements

  • Knowledge of quality systems, regulatory requirements and industry standards
  • Product and testing knowledge
  • Measurement and testing equipment
  • Statistical analysis/research
  • Manufacturing process knowledge
  • Business systems software
  • Office systems software word processing, spreadsheets

Performance Skill Requirements

  • Project management
  • Problem analysis/solving
  • Process management
  • Managing internal and external relationships, influencing

Minimum Experience/Education/Certification Requirements

  • Bachelors degree in Engineering
  • Seven years engineering experience, including managerial experience
  • Medical manufacturing experience
  • Injection Molding experience a plus

Performance Measures (Accountability)

  • Conformance to product requirements quality, timeliness, budget and performance
  • Industry standard and regulatory compliance
  • Staff development and retention

Regular tasks and activities

  • Maintain Standards / ISO Compliance
  • Process Implementation
  • Preventive Quality Engineering techniques
  • Manage Quality Inspection Equipment
  • Manage Supplier Certification
  • Train and develop quality personnel. Hire, manage work hours, vacation requests, review performance, discipline, terminate, make compensation changes, and ensure compliance of engineering personnel to corporate personnel policies.
  • Participate in operation excellence and strategic planning meetings and programs.
  • Supervise and participate in customer service (i.e. telephone calls, installations, start-ups, training and troubleshooting) which may require travel.
  • Professional and timely communication with other departments and customers.
  • Review department expenditures, including compensation, expenses, maintenance and equipment/software upgrades.

 

JunoPacific, a Cretex Medical Company, is a custom medical device design, development, manufacturing and assembly operation supplying clients worldwide with high quality, reliable, and FDA/GMP compliant components and fully kitted medical devices. Join our dedicated team of professionals! http://junopacific.applicantpro.com/jobs/

                                         

 Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

JunoPacific
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