Quality Engineering Tech
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What you'll 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.
What they're looking for
- High School Or Equivalent (Required)
- 5+ Years of Experience in a Manufacturing Environment (Required)
Nice to have
- Associates (Preferred)
- 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)
- Training Any (Preferred)
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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.
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.
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.
Company
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