Quality Engineering Tech

Orchid Orthopedic Solutions; Arab (AL); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Comprehensive benefits

Growth opportunities

Inclusive workplace

Job summary

Orchid Orthopedic Solutions in Arab, Alabama, is seeking a Quality Tech I to ensure manufacturing readiness, sustain process quality, and lead continuous improvement initiatives in our medical device operations. You will update documents, support training, and inspect parts with precision equipment.

The role requires 5+ years in manufacturing, familiarity with FDA/ISO systems, and experience with training. Join a team focused on quality and compliance within a growing organization.

Qualifications

• High School diploma or equivalent required.
• Associates degree preferred.
• 5+ years in a manufacturing environment required.
• Experience in Medical Device Manufacturing preferred.
• Experience with FDA and ISO systems preferred.
• Experience as a trainer preferred.

Responsibilities

• Update controlled documents: forms, procedures, work instructions, policies, and documents.
• Support training programs and ensure regulatory and company requirements are met.
• Inspect parts using precision measuring equipment.
• Collaborate with Sustaining Product Quality and NPI on quality planning.
• Assist in training and use of precision measuring equipment.
• Coordinate with customers on measurement system analysis.

Skills

Communication

Decision Making

ISO 13485

GD&T

Math Aptitude

Problem Solving

Education

High School or Equivalent

Associates Degree Preferred

Tools

Metrology Tools

Job description

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

ABOUT US

Our Arab, Alabama site is just outside Huntsville, offering access to great schools, outdoor recreation, and a low cost of living.

We manufacture precision medical components used in joint, spine, and trauma procedures - work that truly makes a difference. Learn more here.

SHIFT

ALA - Shift 1 ($0) (United States of America - Alabama)

A BRIEF OVERVIEW

The Quality Tech I is responsible for a variety of activities to ensure quality and compliance needs are met. S/he is responsible for manufacturing readiness quality planning, sustaining process quality, continuous improvement initiatives, and compliance adherence.

WHAT YOU WILL DO

• Update controlled documents including Forms, Procedures, Work Instructions, Policies and Documents.
• Support training programs and ensure they meet all applicable regulatory and company requirements.
• Inspects parts using precision measuring equipment
• Works with the Sustaining Product Quality and NPI group as required on the review and/or implementation of Quality planning such as FAR's, FIF's
• Assist the quality team on the implementation, training and use of precision measuring equipment
• Works with customers when measurement system analysis is required
• Performs daily, weekly, and monthly calibration of all measuring equipment other than handheld gages
• Advises all team members on compliance requirements and regulations
• Assists in internal and/or customer audits
• Work with suppliers on quality improvement and process improvement
• Assists with establishing procedures, work instructions, etc. that meet FDA guidelines
• Read and interpret customer drawings and specifications to develop and maintain Quality Inspection Plan and other documents that are part of the Orchid Quality System.
• Participate on cross-functional new and legacy project teams.
• Assist engineers with the conceptualization and development of part fixtures to hold parts during inspection.
• Work with customer and QC to determine customer dimensional and cosmetic acceptance criteria and inspection methods where they are not clearly defined by the customer

EDUCATION QUALIFICATIONS

• High School Or Equivalent (Required)
• Associates (Preferred)

EXPERIENCE QUALIFICATIONS

• Experience in Medical Device Manufacturing (Preferred)
• Experience in Quality-Related Work (Preferred)
• Experience as a Trainer (Preferred)
• Experience with FDA and ISO systems relating to medical devices (Preferred)
• 5+ Years of Experience in a Manufacturing Environment (Required)

LICENSES AND CERTIFICATIONS

• Training Any (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Communication - Basic Knowledge
• Computer Knowledge - Working Experience
• Decision Making and Critical Thinking - Basic Knowledge
• ISO 13485 - Working Experience
• GD&T - Working Experience
• Flexibility & Adaptability - Basic Knowledge
• Manufacturing Industry - Working Experience
• Quality Inspection Metrology Tools - Working Experience
• Mathematical Ability - Working Experience
• Problem Solving - Working Experience

WHAT WE OFFER

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values:
  • Integrity First: We do the right thing
  • Teamwork: We are one Orchid
  • Results: 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 requirements
• Applicants 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 time
• Candidates must be able to provide proof of eligibility to work in the United States through eVerify

At 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.