Job Description

ABOUT US

Orchid’s Arab site in northern Alabama is not far from Huntsville, rated #1 best place to live in the U.S. by U.S. News & World Report 2022-2023. Arab is centrally located to world class recreation and attractions, as well as top-ranked schools and low cost of living.

The Arab, AL site was established in 2007 and joined the Orchid team in 2012. Our 70,000 square foot facility employees approximately 200 team members. We focus primarily on advanced machining of complex instruments for the large joint, spine and trauma markets. Our key products are instruments, implants, and trials. A career at Orchid provides competitive benefits, the ability to take on new responsibilities, and learn and grow in your career. Learn more here.

SHIFT

A BRIEF OVERVIEW
The Quality Tech supports product quality and compliance by helping maintain quality systems, controlled documentation, inspection processes, and measurement programs. This role also plays a key part in building and maintaining electronic inspection guides in quality data collection software, working closely with Engineering, Quality, and Operations to ensure requirements are accurately reflected. Through inspection support, training, calibration, and documentation activities, the Quality Tech I helps ensure products consistently meet internal standards, customer requirements, and regulatory expectations.

WHAT YOU WILL DO

• Build and maintain electronic inspection guides in electronic quality data collection software, such as WinSPC, to support accurate and efficient inspection processes.

• Collaborate cross-functionally with Engineering, Quality, and Operations to confirm inspection guides are complete, accurate, and aligned with product and process requirements.

• Update controlled documents including Forms, Procedures, Work Instructions, Policies and Documents.

• Manage training programs and assure 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

• Conducts final inspection and final process measurement

• 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

• Advocates for the health and safety of self, co-workers, customers, and the community.

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

• Completes all required training.

EDUCATION QUALIFICATIONS

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

EXPERIENCE QUALIFICATIONS

• 2+ Years of Experience in a Manufacturing Environment (Required)
• Experience with quality data collection software (Preferred)
• Experience in Quality-Related Work (Preferred)
• Experience in Medical Device Manufacturing (Preferred)
• Experience as a Trainer (Preferred)

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

PHYSICAL DEMANDS

• Must be able to remain in a stationary position -
• Must be able to move about the inside of the building -
• Must be able to move equipment around the building -
• Must be able to ascend/descend stairs or ladders -
• Must be able to position oneself and move under/around/over equipment -
• Must be able to handle/adjust/inspect/position various items and equipment -
• Must be able to communicate and exchange information with others -
• Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment -
• Must be able to distinguish and detect information such as writing and defects -
• Must be able to move equipment -

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.