Job description

Job description:

Are you searching for new adventures in your career? Are you a Quality Manager with a bachelor’s degree in Manufacturing, Technical, Science, or Engineering discipline? If this sounds like you, do we have the opportunity for you!

Check out our website @ trulife dot com and see for yourself why Trulfe is such a great company to work for, and why you should be a part of our team! Just a few perks of being a Trulife employee, we provide our customers with life changing prosthetics, so you know you are making a difference. On top of that, Trulife is Northwest’s premier manufacturer of aerospace, military, and medical device products with over 60 years’ experience in the manufacturing of niche products. We are seeking a Quality/ Regulatory Manager just like you for out USA manufacturing group. Don't hesitate to make a change for YOU!

Your Role:

Plan, direct, or coordinate quality assurance programs and production activities for the organization.

Ensure compliance with regulatory processes, such as internal audits, inspections, license renewals, or registrations.

May compile and prepare materials for submission to regulatory agencies.

Establishing, maintaining, and improving the Quality Management System

Responsible for Metrology Lab – all equipment and processes including CMM & Laser Tracker programming/operation, document control, and departmental metric.

Hiring, developing, and performance management of a team of quality professionals.

Education/ Experience:

Bachelor’s Degree in Manufacturing, Technical, Science, or Engineering discipline and at least one year of professional experience in regulatory affairs or in quality management systems; OR four years of professional experience in regulatory affairs or in quality management systems position, preferably relating to medical devices and/or Aerospace Manufacturing.

Leading audits for ISO 13485, ISO9001, and AS9100

Knowledge of FDA submission and approval process.

Proficient with Microsoft Office Suite.

Experience with MRP system, preferably SAP; ProShop.

Experience in a manufacturing environment preferred.

Previous experience leading a team of quality professionals.

Personal Qualifications:

Entrepreneurial spirit

Independent & Self-Sufficient leader

Highly organized and detail oriented

Track record of success leading teams through audits

Dynamic/flexible personality

Excellent verbal and written communication skills capable of interacting with a variety of audiences and professions

Must be a U.S. citizen or national, U.S. permanent resident (current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

Trulife is proud to be an Equal Opportunity Employer and is committed to attracting, retaining, and developing a highly qualified, diverse, and dedicated work force. Trulife hires and promotes people on the basis of their qualifications, performance, and abilities. We support the establishment and maintenance of a workplace that fosters trust, equality, and teamwork, in which all employees recognize and appreciate the diversity of individual team members. We provide all qualified applicants for employment and employees with equal opportunities for hire, promotion, and other terms and conditions of employment, regardless of their race, color, religion, gender, sexual orientation, gender identity, national origin/ethnicity, age, physical or mental disability, genetic factors, military/veteran status, or any other status or characteristic protected by federal, state, and/or local law.

Applicants requiring a reasonable accommodation in order to participate in the application and/or interview process, please contact us at 360-598-8977.

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Job Type: Full-time

Pay: $70,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Experience:

• Quality, ISO, or ITAR audit: 1 year (Required)

Work Location: One location

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