Senior Quality Engineer

Combining Strengths. Expanding Possibilities. Tecomet and Orchid are now one company. Explore more at www.tecomet.com.

ABOUT USThe Oregon City, OR Site was established in 1969 and joined the Orchid team in 2012. The site focuses primarily on investment casting and 3D wax printing and machining and finishing and coating of orthopedic implants for extremities and large joint markets.

Robotic wax assembly, internal tool and design, finished machining, polishing, and sintered bead coating are key capabilities of the site. Our 80,000 square foot, FDA registered site employs approximately 175 team members. We ship nearly 1 million hip and knee joint implants to our customers who, in turn, provide solutions that enable patients to live longer, active lives. Fully integrated, our site manufactures medical implants from start to finish complying with the

ISO 13485

2016 standard. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match, and paid time off. For more information, please visit www.orchid-ortho.com.

SHIFTORE

• Shift 1 ($0) (United States of America
• Oregon)

A BRIEF OVERVIEW

The Senior Quality Engineer supports the ongoing quality of Orchid's legacy products across all sites by focusing on a strong relationship with critical customers, working with project management and manufacturing engineers to support new product introductions and ongoing validation, and planning and executing training based on business needs.

WHAT YOU WILL

DOProvides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.

Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniquesActs as a customer liaison and processes customer quality complaints, as applicable.

Collects, Analyzes, and Presents data using statistical methodology Assists suppliers with the interpretation of quality requirements, as applicable. Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Determines machine and/or process capability through planning and/or executing Process Capability studiesDevelops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging. Interfaces with appropriate customer contacts to clarify customer requirementsConceives and/or Leads productivity improvements and/or Continuous improvement projects Monitors engineering production processes and products for adherence to internal and external requirements and practices. Participates in pre

• and post-production launch reviews providing quality engineering supportPerforms quality reviews and internal audits; evaluates data and writes associated reportsRecommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.

Reviews and approves product/process and document change requests. Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques. Supports measuring and analyzing key metrics to monitor performance. Works with cross-functional teams to solve production and quality problems. Creates and manages the overall course structure and sets up course programs based on specifications. Reinforces safety expectations. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor.

Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

EDUCATION QUALIFICATIONS

Bachelor of Science (B.S) (Required)Master of Science (M.S) (Preferred)

EXPERIENCE

QUALIFICATIONS5+ Years of Experience (Required)5+ Years of Experience in a Manufacturing Environment (Preferred)Experience in Medical Device Manufacturing (Preferred)

LICENSES AND

CERTIFICATIONSAny Quality Certification (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE

SUCCESSOperational Functions

• Extensive ExperienceQuality Management
• Extensive ExperienceProcess Management
• Working ExperienceCommunication
• Working ExperienceAccuracy and Attention to Detail
• Working ExperienceManufacturing Safety
• Extensive ExperienceLean Manufacturing
• Working ExperienceStatistical Analysis and Measurement
• Working ExperienceProduction Part Approval Process (PPAP)
• Working ExperienceProduction Runs
• Extensive ExperienceFinal Inspection
• Working ExperienceComputer Knowledge
• Working ExperienceCustomer Communication
• Working ExperienceQSR and ISO
• Extensive ExperienceCoaching
• Working ExperienceInformation Processing
• Working ExperienceLean Assessment
• Extensive ExperienceProblem Solving
• Working ExperienceWHAT WE OFFEROpportunity to work in a growing companyAbility to help people live a longer, more active lifeComprehensive benefit packageAbility to work in an organization that values:

Integrity First:

We do the right thing

Teamwork:

We are one

OrchidResults:

Our results matter

ADDITIONAL REQUIREMENTS

Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirementsApplicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this timeCandidates must be able to provide proof of eligibility to work in the United States through eVerifyAt Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.

Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.

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