Quality Engineering Tech

Orchid MPS Holdings, LLC; Arab, Northern (AL, KY); Hybrid; USD 52,000 - 78,000; Full time

Benefits offered by this job

Comprehensive benefit package

Opportunity to work in a growing公司

Integrity First: We do the right thing

Job summary

Orchid MPS Holdings, LLC is seeking a Quality Tech I to support manufacturing readiness, sustain process quality, and drive continuous improvement. You will update documents, train staff, and ensure compliance with FDA and ISO guidelines while inspecting parts with precision measuring equipment.

You will collaborate with cross-functional teams, perform calibration tasks, and assist in audits and supplier quality initiatives to maintain Orchid's Quality System and drawings-based inspection plans.

Qualifications

• High School or equivalent required; Associate degree preferred.
• Experience in Medical Device Manufacturing is preferred.
• Experience in Quality-Related Work and as a Trainer is preferred.
• Experience with FDA and ISO systems relating to medical devices is preferred.
• 5+ years in a manufacturing environment is required.
• Training experience preferred.

Responsibilities

• Update controlled documents including Forms, Procedures, Work Instructions, Policies and Documents.
• Support training programs and ensure regulatory and company requirements are met.
• Inspect parts using precision measuring equipment.
• Review and implement Quality planning with Sustaining Product Quality and NPI groups.
• Assist with calibration of measuring equipment and participate in audits.
• Collaborate with customers on measurement system analyses as needed.
• Work with suppliers on quality and process improvement.
• Develop procedures and work instructions meeting FDA guidelines.
• Read and interpret customer drawings to maintain the Quality Inspection Plan.

Skills

Communication skills

GD&T

Quality inspection metrology tools

Problem solving

Math skills

Analytical thinking

Reading drawings

Education

High School Diploma or equivalent

Associate degree (Preferred)

Tools

Precision measuring equipment

Job description

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