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Quality Assurance Engineer

2 months ago

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

ABOUT ORCHID ORTHOPEDIC SOLUTIONS

Orchid Orthopedic Solutions is a leader in the manufacturing of medical implants, particularly focusing on hip and knee joint replacements. Our facility is dedicated to producing high-quality products that enhance the lives of our customers.

POSITION OVERVIEW
The Quality Engineer II plays a crucial role in maintaining the quality standards of Orchid's established products while collaborating with project management and manufacturing teams to facilitate the introduction of new products and ongoing validation processes.

KEY RESPONSIBILITIES

  • Complete all necessary training requirements.
  • Utilize quality improvement tools such as process flowcharting, Pareto analysis, and statistical process control to enhance operational efficiency.
  • Act as a liaison for customer quality concerns and manage quality complaints effectively.
  • Collect, analyze, and present data using statistical methodologies.
  • Support suppliers in understanding quality requirements.
  • Contribute to the development of essential Quality Management System (QMS) documents and Advanced Product Quality Planning (APQP) deliverables.
  • Plan and execute process and equipment validations, including installation, operational, and performance qualifications.
  • Engage with customers to clarify their requirements and expectations.
  • Assess 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 quality standards.
  • Participate in pre- and post-production launch reviews, providing quality engineering support.
  • Conduct quality reviews and internal audits, compiling reports based on data evaluations.
  • Recommend modifications to existing quality or production standards to optimize quality outcomes.
  • Review and approve product/process change requests and associated documentation.
  • Evaluate drawings for quality requirements, ensuring proper application of specifications and inspection techniques.
  • Support the measurement and analysis of key performance metrics.
  • Collaborate with cross-functional teams to address production and quality challenges.
  • Promote safety practices and report any safety concerns to management.
  • Adhere to all procedures and work instructions as part of the Quality Management System (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.
  • Prior experience in medical device manufacturing is advantageous.

CERTIFICATIONS

  • Any relevant quality certification is preferred.

SKILLS AND COMPETENCIES

  • Proficient in operational functions and quality management.
  • Experience in process management and statistical analysis.
  • Strong attention to detail and problem-solving abilities.
  • Effective communication skills.
  • Knowledge of lean manufacturing principles.
  • Familiarity with Production Part Approval Process (PPAP) and final inspection processes.

PHYSICAL REQUIREMENTS

  • Ability to remain stationary for extended periods.
  • Occasional movement within the facility and equipment handling.
  • Effective communication and information exchange with team members.
  • Capability to detect and identify quality defects.

WORK ENVIRONMENT

  • Exposure to moderate noise levels.

WHAT WE OFFER

  • Opportunities for professional growth within a dynamic company.
  • The chance to contribute to products that improve lives.
  • A comprehensive benefits package.
  • A commitment to values such as integrity, teamwork, and results.

ADDITIONAL INFORMATION

  • Employment may be contingent upon successful completion of background checks and drug screening.
  • Proof of eligibility to work in the United States is required.

Orchid Orthopedic Solutions is dedicated to fostering a diverse and inclusive workplace and is an equal opportunity employer.