Quality Engineering Tech

Orchid MPS Holdings, LLC; Alabama; Hybrid; USD 45,000 - 60,000; Full time

Benefits offered by this job

Growing company

Help people live longer, more active生活

Comprehensive benefits

Integrity Teamwork Results

Job summary

Orchid Orthopedic Solutions in Alabama seeks a Quality Tech I to manage document control, train staff, and inspect parts using precision measuring equipment. You will coordinate with the Sustaining Product Quality and NPI teams on quality planning and assist with calibration and customer MSA activities.

The role requires strong attention to regulatory requirements, practical knowledge of FDA/ISO systems, and hands-on experience in a manufacturing environment.

Qualifications

• High School diploma or equivalent is required.
• Associates degree preferred.
• 5+ years of experience in a manufacturing environment.

Responsibilities

• Update controlled documents and procedures.
• Support training programs to meet regulatory and company requirements.
• Inspect parts using precision measuring equipment.
• Collaborate with Sustaining Product Quality and NPI on quality planning.
• Assist in calibration of measuring equipment; conduct MSA with customers when needed.

Skills

Communication basics

Computer literacy

Decision making

ISO 13485 experience

GD&T experience

Flexibility

Manufacturing industry

Quality inspection metrology

Mathematical ability

Problem solving

Education

High School Or Equivalent (Required)

Associates (Preferred)

Job description

ABOUT US

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

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.

We are a leading metal and materials innovator and contract manufacturer, with a large presence in orthopedic implants.

Watch this video to see how orthopedic procedures impact the lives of our friends and family. Find more information here: Website: www.orchid-ortho.com Website: https://tecomet.com/ Hear why two employees are proud to be a part of the team in this video.

We are committed to maintaining an environment of Equal Opportunity and Aff

For application accommodation, visit any of our facilities, e-mail [e-mail] or call [phone] x80910. Arab, AL Santa Ana, CA