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Quality Engineering Tech

Orchid Orthopedic Solutions · Arab, AL

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Level
Engineer
Team
Quality
Experience asked
5+ years
Industry
Medical devices
Posted
30+ days ago

The role in 30 seconds

An engineer-level quality role at Orchid Orthopedic Solutions (medical devices) in Arab, AL. S/he is responsible for manufacturing readiness quality planning, sustaining process quality, continuous improvement initiatives, and compliance adherence.

They ask for
5+ years
Tools it names
GD&T, ISO 13485, FDA / GMP, Tooling

Read from the posting. The full description is below.

How this role compares

Against 10 other live quality postings in Alabama.

Experience asked
Typical (5+ years)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • Root cause 73%
  • Supplier quality 55%
  • Team leadership 45%
  • ✓ GD&T 45%
  • Control plans 36%
  • Lean 36%

✓ = this posting asks for it too. % = share of similar postings that mention it.

Stands out: this posting asks for ISO 13485, FDA / GMP, Tooling, which few similar roles mention. If you have it, lead with it.

It asks for 5+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Training program

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Quality team at Orchid Orthopedic Solutions

    Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.

  2. 2

    Send a short, curious note

    One real question about their work. No favors yet. Each person gets a different note, written for this role.

  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • How did you land the job? What stood out in your interviews?
  4. 4

    Apply with someone vouching for you

    If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.

  5. 5

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

Full description from Orchid Orthopedic SolutionsAs posted on their careers site.Show

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

Qualifications

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

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)

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

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.

Show full 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)

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 .

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.

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

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