• 30-Aug-2017 to 29-Oct-2017 (EST)
  • JP Quality
  • Anoka, MN, USA
  • Salary
  • Full Time

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

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

The Quality Manager will build, manage, and lead the quality assurance department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality for JunoPacific products. This role will develop and implement effective, robust quality management system processes and methods in alignment with the FDA QSR and ISO requirements, and utilize metrics to continually improve quality processes and efficiency.

Essential Job Functions:                                                               

  • Develop, deploy, and execute Quality Policies, Quality Objectives, and Quality Plans that are in line with and support the corporate strategic business goals and Quality Management System
  • Support, develop, implement, and maintain all QMS processes and procedures, including but not limited to; Complaint Handling, Design and Development, Change Control, Risk Management, Corrective and Preventive Action, Internal Audits, Supplier Quality, Process Control, Document Control and Identification and Traceability
  • Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements
  • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control and Corrective and Preventive Actions to the adhered timelines as appropriate
  • Responsible for implementation, support, and maintenance of computer system modules used for QMS processes
  • Monitor and audit the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement, ensuring continued certification to ISO 13485
  • Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality system processes. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate
  • Collect, analyze, and present data on the QMS during Management Review Meetings. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause corrective action
  • Act as a representative for audits from external regulatory authorities and registration agencies
  • 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)

  • Bachelor's degree in an applicable technical discipline (Engineering, Sciences, Quality, preferred)
  • 5 + years of experience in Quality Assurance or a Bachelor's degree and a minimum of 3 years of Quality Experience or 3+ years of supervisory experience in the medical device industry or related management experience in manufacturing engineering or operations in a medical device organization
  • Hands-on experience within an ISO quality system; direct experience with ISO 13485, ISO 14971 and GMP
  • Specific experience and/or training in auditing, training, writing procedures, supplier quality assurance, verification and validation, and creating management level presentations and reports
  • In depth knowledge of FDA Quality System Regulation, Good Manufacturing Practices, 21 CFR Part 820 and Cleanroom standards
  • Excellent working knowledge of quality tools, sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma
  • Demonstrated leadership skills with the ability to build and maintain an efficient, effective organization with a team focused on continual improvement
  • Professional and timely written and verbal communicator with internal and external customers
  • Adaptable with the ability to promote change assertively with tact and diplomacy
  • A team player who can work well with production personnel, peers and management, who delivers pragmatic but sound quality solutions to identified issues
  • Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timelines
  • Ability to use Microsoft Office (Word/Excel/PowerPoint), IQMS ERP and other business related systems and working knowledge of statistical software
  • Self-motivated with a strong work ethic
  • Communicate and advocate company goals, policies and initiatives
  • Structure, lead, train, develop and retain staff for maximum effectiveness
  • Carry out supervisory responsibilities in accordance with the company's policies and applicable laws. Responsibilities include but are not limited to: planning, assigning and directing work, communicating and appraising performance on an ongoing basis, completion of timely performance reviews, rewarding and disciplining employees, addressing issues and resolving problems
  • 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

Desirable Criteria & Qualifications                                   

  • Formal education in Quality (CQE / CQM)
  • Continuing Education; including participation in local chapters, associations, and/or organizations
  • Ability to consistently achieve short and long term business results

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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.

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