Quality Engineering Tech II

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.

SHIFT

A BRIEF OVERVIEW

The Quality Tech II 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.
• 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
• 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
• 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.