Quality Assurance Engineer (Devices)

The Quality Assurance Engineer is part of a team responsible for ensuring Northgate Technologies medical devices meet the highest standards for quality, accuracy, operating functionality, and reliability. Working directly on quality assurance (establishing through objective evidence that the product meets the design requirements) this position will oversee quality for the overall solution functionality, design and manufacturing workflow. You will work among a team of engineers, technicians, developers and project managers for direction, support and collaboration. 

CORE COMPETENCIES

1. Humble - Ability to act with courtesy, work with confidence, and not demonstrate arrogance; ability to be open-minded and  ready to learn from others
2. Hungry - Ability to act first or on your own without prompting by others; ability to introduce something new, e.g. product, service, or process; future-focused
3. Smart - Ability to identify and harness the emotions of others and yourself to achieve positive outcomes 
4. Accountable - Ability to take ownership of work and deliver on expected outcomes, e.g. timeliness, quality, quantity, etc.
5. Team Player - Ability to work effectively and collaboratively as part of a group of people that is responsible for a shared outcome

FUNCTIONAL COMPETENCIES

1. Analytical Thinking - Review the data/information we are presented with (for relevance, patterns, trends etc.)
2. Investigative - Examine or inquire into something systematically in an attempt to learn the facts about something hidden, unique, or complex
3. Policies and Procedures - Eliminate redundancies and improve process efficiency and effectiveness
4. Process Improvement - Eliminate redundancies and improve process efficiency and effectiveness
5. Thoroughness - Ability to give appropriate attention to detail

KEY DELIVERABLES

1. Establish Policies and Procedures

• Establish activities for the development, application and maintenance of quality standards for processes, Finished devices, materials, and other products.
• Develop standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such electrical, and mechanical. 
• Develop sampling procedures, forms and instructions for recording, evaluating, and reporting quality and reliability data. 
• Develop methods and procedures for disposition of discrepant material and devise methods to assess cost and responsibility. 
• Collaborate with Regulatory affairs to meet the requirements of the FDA and Medical Device Directive 
• Manage CAPA program for areas of responsibility 

2. Provide Insight

• Ensures management representation, when required, at audits of the quality system

3. Support Product Development and Manufacturing

• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability
• Organizes, writes and conducts training sessions on quality control activities.
• Plans all required test fixtures and tools for the correctness of components and products

4. Health and Safety

• Contribute to a safe work environment by complying with all federal & state laws, Northgate policies, procedures and OSHA, if applicable

QUALIFICATIONS, SKILLS AND WORKING CONDITIONS

Minimum Required Education and Experience

• Bachelor’s degree in Engineering (Electrical Preferred)
• 5 Years of experience in manufacturing/quality
• 2 Years work experience with regulated electro-mechanical medica products in a manufacturing environment
• Ability to manage multiple, simultaneous projects and deadlines
• Ability to synthesize and document requirements
• Excellent written and verbal communication skills
• Must be able to work independently, in a team environment, and with cross-functional teams
• Working knowledge of Statistical software package Minitab, InfinityQS, Microsoft Word and Excel
• Experience in internal auditing of Quality Management Systems

Preferred Skills or Knowledge

• Certified Quality Engineer
• Knowledge of CAD design software

Working Conditions

• Clean office environment
• Minimal travel, including international, as needed

At NTI, we are passionate about innovation and improving minimally invasive surgery. Since 1984, we’ve taken part in advancing laparoscopic surgical techniques by offering a growing portfolio of innovative, reliable and easy-to-use products and services. This passion has earned us recognition! NTI received the 2022 Innovation of the Year Award from the Society of Laparoscopic & Robotic Surgery and also won a 2023 Edison Award, which honors the best in innovation and innovators! We know we can't do any of it without our talented employees! Our corporate culture revolves around our five core values: respect, trust, integrity, duty and innovation which we live and breathe every day. We are always grateful to have accomplished team members join us and help us strengthen our values. We offer competitive compensation, a strong benefits package, including paid time off and 401k with company match. NTI places high importance on the alignment of an individual’s experience with our business goals and initiatives. Join our team today!