Job Description

About Us

We value people that are highly motivated, self-starters open to learning new things every day. We’re looking for people with a good attitude and strong character who strive to be the best at what they do, take accountability for their actions and are determined and committed to get the job done. We’re highly collaborative, innovative thinkers and we need people from diverse backgrounds and levels of experience to join our growing team. We’ve built our workplace on inclusivity treating everyone with respect and integrity and providing people with the support and space to do their best work.

Position Summary

Reporting to VP of Operations, the Quality Manager will understand the annual business strategy and lead the success of the Quality function (Quality Systems & Production Quality) in support of it. In addition to production quality, this position will own full responsibility of the Quality Management System, annual certifications, and cross-functional, enterprise wide, Quality continuous improvement. Ultimately, the Quality Manager must produce measurable success.

The ideal candidate must bring prior success leading functionally & cross-functionally, have a strong quality & technical track record and be ready to make an impact.

Compensation, Benefits & Fun Stuff

• Check out our benefits, both the essentials and the extras, here. Find out what it’s like to work at Praxis,here.
• Comprehensive medical, dental, vision & life insurance plan: $1/month employee contribution to medical premiums
• 401k Retirement Plan
• Profit Share Program
• Annual Performance Bonus
• Paid time off -18 days first year (prorated)
• Paid holidays -9 days
• Tuition Assistance
• Be a part of a locally owned & operated business, who values treating everyone with integrity & respect
• Be a part of a progressive company who strives to reinvest in their staff

What You Must Bring to This Role

· Bachelor’s Degree in Engineering or other applicable area of study

· Proven experience with total QMS oversight and certifications

· Overwhelming success in leading sustainable change within Quality

· History of success growing and leading Quality department

· Outstanding grasp of Lean and Root Cause Corrective Action method(s)

**Must have Med Device Experience and 13485

How You’ll Make an Impact

• Understand the annual business strategy and lead the success of Quality Department initiatives; both Quality Systems & Production Quality
• Responsible for the development of strategies and tactics for the Quality Department to deliver continuously improving measurable outcomes
• Complete oversight of Quality Management System for an ISO-13485 / AS9100 Certified Contract Manufacturing company
• Maintain all notified body Company Certifications and continuously improve the QMS
• Accountable to evaluate and establish the plan for use of 3rd party resources & maximizing their measured effectiveness
• Lead Continuous Improvement initiatives to drive measurable success through contemporary Quality practices, Lean and enterprise wide Corrective Action Preventative Action (CAPA) methods and processes

Working Conditions & Physical Efforts

• Work is performed in a Production environment
• May be required to lift up to 50 lbs.
• Ability to stand or sit for a prolonged period of time
• Visual functions being those of near vision, depth perception, and ability to adjust focus
• Talking and hearing occur continuously in the process of communicating with leadership & clients
• Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard or operate equipment
• Low exposure to physical risk

Compensation Range: 110 - 120k

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