Quality Assurance Engineer

2 weeks ago

Oregon City, Oregon, United States Orchid Orthopedic Solutions Full time
Job Overview

ABOUT ORCHID ORTHOPEDIC SOLUTIONS

Established in 1973, our Oregon City facility has been a part of the Orchid family since 2012. Spanning 80,000 square feet, we are home to around 300 dedicated professionals. Our focus is on the production of hip and knee joint implants, empowering our clients to lead active and fulfilling lives. A career with us offers numerous growth opportunities, an attractive benefits package including performance bonuses, comprehensive insurance, a 401(k) plan with company contributions, and paid time off.

SHIFT DETAILS

No Shift ($0) (United States of America)

POSITION SUMMARY
The Quality Engineer II plays a crucial role in maintaining the quality of Orchid's established products while collaborating with project management and manufacturing engineers to facilitate new product introductions and ongoing validation efforts.

KEY RESPONSIBILITIES

  • Complete all mandatory training programs.
  • Utilize quality improvement tools such as process flowcharting, Pareto analysis, and statistical methods to drive enhancements.
  • Serve as a liaison for customer quality issues and manage quality complaints as necessary.
  • Gather, analyze, and present data employing statistical techniques.
  • Assist suppliers in understanding quality standards as required.
  • Contribute to the development of key Quality Management System (QMS) deliverables, including complaint analysis and risk assessments.
  • Plan and execute process and equipment validations, including installation, operational, and performance qualifications.
  • Engage with customer representatives to clarify quality requirements.
  • Evaluate machine and process capabilities through Process Capability studies.
  • Develop inspection criteria that align customer expectations with manufacturing processes.
  • Lead initiatives for productivity enhancements and continuous improvement projects.
  • Monitor production processes to ensure compliance with internal and external standards.
  • Participate in production launch reviews, providing quality engineering insights.
  • Conduct quality reviews and internal audits, compiling relevant reports.
  • Recommend updates to existing quality or production standards to optimize quality within equipment capabilities.
  • Review and authorize product/process and document change requests.
  • Examine technical drawings to ensure adherence to quality specifications.
  • Support the measurement and analysis of key performance metrics.
  • Collaborate with cross-functional teams to address production and quality challenges.
  • Promote safety standards and practices within the workplace.
  • Ensure compliance with all QMS procedures and documentation.

EDUCATIONAL REQUIREMENTS

  • Bachelor of Science (B.S) degree is required.

EXPERIENCE REQUIREMENTS

  • A minimum of 3 years of relevant experience is required.
  • Experience in a manufacturing setting is preferred.
  • Background in medical device manufacturing is advantageous.

CERTIFICATIONS

  • Any quality-related certification is preferred.

SKILLS AND KNOWLEDGE FOR SUCCESS

  • Operational Functions - Practical Experience
  • Quality Management - Practical Experience
  • Process Management - Practical Experience
  • Communication - Basic Understanding
  • Attention to Detail - Practical Experience
  • Manufacturing Safety - Practical Experience
  • Lean Manufacturing - Practical Experience
  • Statistical Analysis - Practical Experience
  • Production Part Approval Process (PPAP) - Practical Experience
  • Final Inspection - Practical Experience
  • Computer Proficiency - Practical Experience
  • Problem Solving - Practical Experience

PHYSICAL REQUIREMENTS

  • Ability to remain stationary for extended periods - Frequently
  • Ability to navigate within the facility - Occasionally
  • Ability to move equipment as needed - Occasionally
  • Ability to position oneself around equipment - Occasionally
  • Ability to communicate effectively with others - Frequently
  • Ability to discern and detect details such as writing and defects - Frequently

WORK ENVIRONMENT

  • Noise levels - Occasionally

WHAT WE PROVIDE

  • Opportunity to contribute to a growing organization
  • Ability to positively impact lives through our products
  • Comprehensive benefits package
  • Work culture that values:
    • Integrity: We prioritize ethical practices
    • Teamwork: We function as one cohesive unit
    • Results: Our outcomes are significant

ADDITIONAL NOTES

  • Candidates may be required to undergo a pre-employment background check and drug screening based on the role.
  • Eligibility to work in the United States must be verified through eVerify.

At Orchid, we are committed to fostering a diverse and inclusive workplace and are proud to be an equal opportunity employer. All qualified candidates will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, or disability.

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