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. Responsibility includes managing Compliance Wire to ensure all training is issued and management team is notified when training is past due.
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

• 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

• 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

• 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.

• Manage Compliance Wire and ensure all training is issued timely, ensure management is aware of overdue training in their departments
• Attend GEMBA walks weekly to ensure the shop floor has all tooling/gages required to perform each job

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

EOE, including disability/vets