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Quality Engineering Tech

External
orchidortho logoOrchidortho · Arab, AL
Full-timeOn-site2w ago
ComplianceProcess Improvement
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About the role

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 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.

Responsibilities

  • 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
  • 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
  • EDUCATION QUALIFICATIONS
  • High School Or Equivalent (Required)
  • Associates (Preferred)
  • EXPERIENCE QUALIFICATIONS
  • Experience in Quality-Related Work (Preferred)
  • Experience in Medical Device Manufacturing (Preferred)
  • Experience as a Trainer (Preferred)
  • 2+ 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

Benefits

Opportunity to work in a growing companyAbility to help people live a longer, more active lifeComprehensive benefit packageAbility to work in an organization that values:Integrity First: We do the right thingTeamwork: We are one OrchidResults: Our results matterADDITIONAL REQUIREMENTSCandidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirementsApplicants 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 timeCandidates must be able to provide proof of eligibility to work in the United States through eVerifyOrchid 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.

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