Quality Assurance Engineer

2 weeks ago


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

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 expertise lies in the production of hip and knee joint implants, enabling our clients to enjoy longer, active lives. At Orchid, we offer a fulfilling career path with opportunities for advancement, a competitive benefits package including performance bonuses, comprehensive insurance, a 401(k) plan with company matching, and generous paid time off.

SHIFT DETAILS

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

POSITION OVERVIEW
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 processes.

KEY RESPONSIBILITIES

  • Complete all mandatory training requirements.
  • Utilize quality improvement tools such as process flowcharting, Pareto analysis, and statistical methods to enhance processes.
  • Serve as a liaison for customer quality concerns and manage quality complaints as necessary.
  • Gather, analyze, and present data employing statistical methodologies.
  • Assist suppliers in understanding quality requirements.
  • Contribute to the development of essential 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 customers to clarify their requirements.
  • Evaluate machine and process capabilities through Process Capability studies.
  • Develop inspection criteria that align customer requirements 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 pre- and post-production launch reviews, providing quality engineering support.
  • Conduct quality reviews and internal audits, analyzing data and preparing reports.
  • Recommend modifications to existing quality or production standards to optimize quality within equipment capabilities.
  • Review and approve product/process and document change requests.
  • Examine drawings to assess quality requirements, ensuring correct application of 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 ensure adherence to safety practices.
  • Maintain compliance with all procedures and work instructions as per the Quality Management Systems (QMS).

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 environment is preferred.
  • Background in medical device manufacturing is advantageous.

CERTIFICATIONS

  • Any Quality Certification is preferred.

ESSENTIAL SKILLS AND KNOWLEDGE

  • Operational Functions - Proficient experience.
  • Quality Management - Proficient experience.
  • Process Management - Proficient experience.
  • Communication - Basic knowledge.
  • Attention to Detail - Proficient experience.
  • Manufacturing Safety - Proficient experience.
  • Lean Manufacturing - Proficient experience.
  • Statistical Analysis - Proficient experience.
  • Production Part Approval Process (PPAP) - Proficient experience.
  • Final Inspection - Proficient experience.
  • Computer Skills - Proficient experience.
  • Problem Solving - Proficient experience.

PHYSICAL REQUIREMENTS

  • Ability to remain stationary for extended periods.
  • Occasional movement within the facility.
  • Occasional handling of equipment.
  • Ability to navigate around equipment.
  • Frequent communication and information exchange with others.
  • Frequent ability to detect and distinguish information.

WORKING ENVIRONMENT

  • Noise levels may vary.

WHAT WE PROVIDE

  • Opportunity to contribute to a growing organization.
  • Chance to positively impact lives through our products.
  • Comprehensive benefits package.
  • Work culture that emphasizes integrity, teamwork, and results.

ADDITIONAL INFORMATION

  • Employment may be contingent upon passing a background check and drug screening.
  • Proof of eligibility to work in the United States is required.

At Orchid, we are committed to fostering a diverse and inclusive workplace and are proud to be an equal opportunity employer. All qualified applicants 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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