ABOUT US The Oregon City facility has been a cornerstone in the industry since 1973, becoming part of the Orchid team in 2012. Spanning 80,000 square feet and employing around 300 dedicated professionals, we specialize in manufacturing hip and knee joint implants that empower people to live active and fulfilling lives. Our comprehensive operations allow us to handle all aspects of medical implant production in-house. Joining Orchid means accessing growth opportunities, an attractive benefits package including performance bonuses, insurance, a 401(k) with company match, and paid time off. SHIFT No Shift (United States of America) A BRIEF OVERVIEW The Lead Quality Engineer will play a crucial role in maintaining the quality of Orchid's legacy products across all locations. This role focuses on building strong relationships with key customers, collaborating with project management and manufacturing engineers on new product introductions and ongoing validation, and developing training programs based on the business's evolving needs. WHAT YOU WILL DO Deliver comprehensive training on work instructions, policies, and procedures to ensure team members are competent and confident in their roles.

Utilize quality improvement tools, including process flowcharting, Pareto analysis, and statistical methods, to drive enhancements within the organization.

Act as the primary customer liaison for processing quality complaints, ensuring timely and effective resolutions.

Collect, analyze, and present data using rigorous statistical methodologies to inform decision-making.

Guide suppliers in understanding and meeting quality requirements.

Contribute to essential Quality Management System (QMS) documents and Advanced Product Quality Planning (APQP) activities, such as complaint analysis and risk management.

Plan and conduct validation activities, including installation, operational, and performance qualifications.

Evaluate machine and process capabilities through systematic Process Capability studies.

Design inspection criteria aligning customer expectations with manufacturing processes, identifying critical characteristics and appropriate sampling plans.

Collaborate with customer contacts to clarify and define quality requirements.

Initiate and lead continuous improvement initiatives to enhance productivity.

Monitor production processes and products, ensuring compliance with internal and external quality standards.

Engage in pre- and post-production launch reviews, providing quality engineering insights.

Conduct quality reviews and internal audits, assess data, and compile reports with recommendations.

Suggest modifications to enhance existing quality or production standards within the facility's capabilities.

Review and approve product/process and document change requests.

Evaluate technical drawings for quality requirements, ensuring proper application of geometric dimensioning and tolerance standards.

Measure and analyze key performance metrics to track production performance.

Work collaboratively with cross-functional teams to resolve production and quality challenges.

Develop and manage training programs promoting safety and operational best practices.

Support quality and compliance initiatives by strictly adhering to QMS protocols.

EDUCATION QUALIFICATIONS Bachelor of Science (B.S) (Required)

Master of Science (M.S) (Preferred)

EXPERIENCE QUALIFICATIONS 5+ Years of Experience (Required)

5+ Years of Experience in a Manufacturing Environment (Preferred)

Experience in Medical Device Manufacturing (Preferred)

LICENSES AND CERTIFICATIONS Any Quality Certification (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS Extensive experience in operational functions and quality management.

Working knowledge in process management, communication, and attention to detail.

Profound understanding of manufacturing safety and lean practices.

Familiarity with statistical analysis and measurement.

Experience with customer communication and document processing standards.

Thorough experience with QSR and ISO requirements.

Ability in coaching and problem-solving within teams.

WHAT WE OFFER Opportunity to work with a growing and innovative company. Make a difference in helping people lead healthier, more active lives. A comprehensive benefits package. Be part of an organization that values integrity, teamwork, and results. ADDITIONAL REQUIREMENTS Candidates may be required to undergo a pre-employment background check and drug screening. Proof of eligibility to work in the United States is required. At Orchid, we actively promote a diverse and inclusive workplace and are proud to be an equal opportunity employer. All qualified applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, or disability.