Quality Lead - 7am-7:15pm

QUALITY LEAD

Actively Hiring – Immediate Openings

Hours: full-time position.

Competitive pay & benefits: paid overtime, health, dental, vision, paid time off, 401k with match… and more!

“Come Build your Career in our Growing, Fast-Paced, Customer-Focused Company that fosters Training & Professional Development!”

WHAT YOU WILL DO:

“Quality & Safety are Top Comar Priorities”

• Perform Quality Technician and Quality Inspector duties, including inspection/testing, audit, calibration, quality documents control management, data collection system set up and maintenance.
• Perform quality review of all completed batch records and provide explanations of required corrections to manufacturing operations and QC inspectors. Maintain batch records.
• Review COAs and perform any required testing/inspection for all incoming materials.
• Perform maintenance of controlled documents, including work instructions, Standard Operating Procedures (SOP’s), training records, etc.
• Administer the document change process for new work instructions, SOPs, etc. Act as a subject matter expert for the Enterprise Resource Planning system, IQMS, with regards to document control.
• Complete inspections and data charts for mold qualifications and special quality assurance projects.
• Perform Tool/Line validation protocol and compile results.
• Conduct GMP (Good Manufacturing Practice) and line audits.
• Manage Certificates of Conformance and Analysis process.
• Process customer sales samples and generate COCs for finished products.
• Write deviations and nonconformance reports as required, and assist operations with investigations, root cause analysis, and determining corrective actions.
• Train quality and production staff on defect recognition and quality assurance processes
• Develop, Train and Onboard Quality Team including Quality Technicians I, II, III.
• ISO13485 additional position responsibilities:
  • Provide support and guidance to operations on the floor with respect to ISO 13485 and cGMP requirements.
  • Support ISO 13485 and cGMP awareness, training, and monitoring.

Safety and Cleanliness

“We have put in place Covid-19 practices for our employees’ safety”

• Adhere to safety policies.
• Maintain a clean and safe work area and report any unsafe conditions to supervisor.
• Wear company issued personal protective equipment (PPE) such as uniforms, gloves, masks, hairnets.

WHO WE ARE LOOKING FOR:

“A Comar employee who will represent the customer and be the consumer’s advocate”

Are You…?

• High school or Vo-Tech graduate with 6 years of experience in Quality Control OR an Associate degree in a scientific discipline with 4 years of Quality Control experience.
• Experience in an ISO certified or regulated environment.
• Proficient with computers, software, and Statistical Process Control (SPC) tools and techniques.
• Proficient with Gauge Repeatability and Reproducibility (Gauge R&R)
• Proficient with process validation tools and techniques and familiarity with ISO 9001 and/or ISO 13485.
• Experience in onboarding, developing and training new quality technicians on all processes, standard operating procedures, tools and techniques, as well as computers, SPC and Guage R&R.

Preferred:

• Bachelor’s degree in science, technology, engineering or significant applicable experience, training, and certifications.
• Experience working in medical device, food manufacturing, or clean room environments and experience working in a GMP quality role.
• Experience with environmental monitoring and visual inspection standards and processes.
• Knowledge of Regulated Industry: CFR Part 820 Quality System Requirements, the ISO family of standards, particularly ISO 13485 and 9001, and others as needed.
• Knowledge of the safety requirements and complexity of working with automated and semi-automated production and inspection systems in a factory environment.

Do You…?

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to work independently and in a team environment.
• Skilled at learning the use of equipment for dimensional analysis.
• Detail-oriented with strong capability of discovering nonconformances in both paperwork and materials.
• Skilled in basic math: add, subtract, multiply, divide, compute rate, ratio, and percent.
• Carry out written, oral, or visual / diagram instructions.
• Strong relationship building skills with the ability to speak effectively before groups of customers or employees, and to communicate job-related functions with other employees, cross-department, customers and auditors as needed.
• Ability to troubleshoot and diagnose measurement system errors.
• Ability to author work instructions for quality related materials and processes (e.g. SPC, Calibration, Gauge R&R and Testing).
• Ability to interpret product drawings and specifications and write routine reports.
• Display strong leadership and organizational skills.
• Ability to onboard, develop, train, prioritize, plan, organize and coordinate work across Quality Technicians I, II, III.
• Ability lead quality improvement projects and lead the quality team in absence of management.

Do you Enjoy Physical Work where you will…?

• Stand for most of the work shift.
• Use hands and fingers to handle or feel; reach with hands and arms; stoop, crouch, bend, twist, and only occasionally sit.
• Lift and/or move up to 10 pounds. Heavier amounts can be moved with assistance of equipment.

If the answer is YES, don’t delay, Apply Today!