Juno Pacific
  • 21-Feb-2020 to 21-Apr-2020 (EST)
  • JP Quality
  • Anoka, MN, USA
  • Salary
  • Full Time

Medical, Dental, Vision, 401k, Profit Sharing, Short-Term Disability, Life Insurance, PTO

A 100-year tradition of quality

Cretex is a diversified family of manufacturing companies serving the medical market. Our companies share a common set of values, a common management system, and a pervasive focus on quality, customer service and responsiveness. We've been around for 100 years and by doing the right things well, we plan to be around for many more.

Upholding a true standard for ethical excellence

For nearly a century, Cretex has earned a reputation for consistently holding true to the core principles of honesty and integrity. Our employees take great pride in their work and the level of service they offer our customers. Because of this, our companies continue to earn the highest level of confidence and loyalty from our customers, suppliers, employees, owners and stakeholders.

Bringing the best together through technology and talent.

The Cretex Medical family of companies provide a broad range of contract manufacturing solutions to medical device OEMs. Our private ownership, long-term perspective and strong financial portfolio allow us to invest in the leading-edge manufacturing technologies and engineering resources required to meet the most exacting requirements of the medical device industry. Our growing portfolio of companies include rms, rms Surgical, Meier, JunoPacific, Spectralytics and QTS; providing manufacturing capabilities that include precision machining, plastic injection molding, micro stamping, metal forming, laser micromachining, surgical instruments and clean room assembly and packaging.

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.

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!

Position summary

Provide quality assurance engineering expertise, technical guidance, compliance support, and quality standards for medical molding and contract manufacturing. Utilize quality tools and problem-solving techniques in determining root cause on product or process issues. Prepare necessary protocols, reports, and submission packages for new product introduction. Develop and implement advanced dimensional and visual inspection plans and results for various manufacturing processes. 

Essential Job Functions                                                                

  • Knowledge of Injection Molding for medical customers
  • Medical device quality systems: ISO 13485, 27186,5841-3, and FDA Parts 820 and 210 (cGMP)
  • Quality engineering support for manufacturing and project management. Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as APQP, control plans and inspection plans
  • Support customer and supplier qualification audits, as a key member of the NPI Quality team, when necessary
  • Develop and implement IQ, OQ, PQ, MVP and PV documentation to support new tooling and assembly operations
  • Interface with customers and suppliers on new product introductions, coordination of measurement alignments, and sustaining needs
  • System analysis of techniques and procedures to determine hardware, software, and fixture needs for NPI and sustaining programs
  • Develop, program, document, design, analyze, create, and test various precision testing equipment including but not limited to Tool Scope, CMM, and Vision Systems
  • Analyze data and identify improvement opportunities. Data will be the results of statistics, sampling and process capability studies
  • Work with engineering, manufacturing, and quality teams to implement effective inspection, standard operating procedures, work instructions, and control plans for new product development
  • Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis
  • Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions
  • Advanced level understanding of Geometric Dimensioning and Tolerance (GD&T)
  • Subject matter expert in the use of statistical tools, including: sample size determination / rationale, DOE, SPC, Gage R&R, and process capability analysis
  • Support and train Quality Inspectors and Technicians to ensure that inspection plans comply with the relevant requirements of customer's product requirements, methodology, and techniques
  • Subject Matter Expert in: Quality Engineering
  • Monitors the utilization of employee safety and OE programs
  • Partners with the other business segments: sales/marketing, customer service, engineering, quality, and finance
  • Understands customer needs and the core business markets we serve
  • Ensures business systems are implemented, maintained, and functioning properly
  • Participates in required company meetings
  • Maintains an organized work area (5S)
  • Participates in the Operational Excellence Program
  • Supports and complies with the company's Quality System, ISO, and medical device requirements
  • Completes all other work duties as assigned

Minimum Requirements, Education & Experience (incl. KSA's and certifications)

  • Knowledge of quality systems, regulatory requirements and industry standards
  • Blueprint reading and GD&T expertise
  • Operation inspection equipment
  • Statistical expertise with DOE and Capability Studies
  • Design software- Minitab
  • Process management
  • Excellent communication and influencing skills
  • High level of energy, personal accountability and integrity
  • Highly detail oriented; checks own work, keeps accurate records, organizes information effectively
  • Ability to tolerate ambiguity, multiple priorities and short deadlines
  • Ability to travel overnight, by land or air
  • Bachelor's Degree: Mechanical, Industrial, or other Engineering science or 7+ years of Quality Experience in a manufacturing setting or the collective education, background, training, and experience to assure that all activities required are correctly performed
  • Ability to consistently achieve short and long-term business results
  • Ability to prioritize work and manage multiple tasks when needed
  • Ability to follow through on commitments and holds team members accountable
  • Good attention to detail
  • Good communication skills
  • Strong problem solving skills
  • Ability to use Microsoft Office (Word/Excel/PowerPoint) and ERP and other business related systems
  • Leadership Skills (train, develop, and motivate employees)

Desirable Criteria & Qualifications

  • Certifications: ASQ-CQE
  • Continuing Education; including participation in local chapters, associations, and/or organizations

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.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify

Juno Pacific
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