- Team Leadership: Lead, mentor, and develop a team of quality engineers, fostering a collaborative and high-performance environment focused on product excellence.
- Quality Integration: Embed quality assurance into manufacturing as a value-added function, performing root cause analysis, and driving data-based improvements.
- Regulatory Compliance: Ensure compliance with regulatory requirements and standards throughout the product lifecycle, from design and development to manufacturing.
- Design Control: Oversee design control processes and evaluate changes to design or manufacturing for their impact on device history files (DHF), ensuring any gaps are addressed.
- Risk Management: Lead product and process risk assessment activities, including hazard analysis and failure modes & effects analysis (DFMEA/PFMEA).
- Product Qualification: Manage product and process qualification activities, including complaint investigations, engineering studies, and statistical process control (SPC).
- Quality Methods: Develop and implement sampling, inspection, defect recognition, and product testing methods, utilizing statistical and quality engineering knowledge.
- Continuous Improvement: Promote continuous improvement through timely handling of investigations, risk assessments, deviations, non-conformance reports (NCRs), and corrective and preventive actions (CAPAs).
- Audit Support: Act as a subject matter expert during internal and external audits, providing expertise on device and Quality Management Systems (QMS).
- Experience: Minimum 6 years in a quality engineering role within the medical device industry, including leadership experience.
- Leadership Skills: Proven ability to lead and develop a team, with strong interpersonal and communication skills.
- Technical Proficiency: Expertise in statistical techniques, design of experiments, and quality management software. Familiarity with 21 CFR 820, ISO 13485, ISO 14971, and FDA GMP practices.
- Regulatory Knowledge: In-depth understanding of medical device regulations and standards, with knowledge of MDSAP, EU MDD/MDR as a plus.
- Project Management: Ability to manage multiple projects and priorities in a fast-paced environment.
- Educational Background: Bachelor's degree in Engineering, Quality Management, or a related field. ASQ CQE certification preferred.
- Be part of a dynamic and innovative team at the forefront of medical device manufacturing.
- Lead impactful projects that enhance patient safety and product reliability.
- Enjoy opportunities for professional growth and development in a supportive environment.
-
Engineering Management
2 weeks ago
Tetra Tech Salt Lake City, United States Full timeTetra Tech, an industry leader and nationally recognized engineering and consulting firm, is seeking professional, motivated, and intelligent candidates to fill an Engineering Management position for our Federal Environmental Permitting and Compliance team. The person selected wi ...
-
Velocity Solutions Lake City, United StatesSince 1979, the name WEBER has stood for innovative solutions in cutting-edge technology. With over 250 highly qualified employees, we realize customer requests from the planning and design of products, assemblies, and special machines to electronics development and testing, as w ...
-
Stability Engineering Manager
2 weeks ago
Ultradent Salt Lake City, United States Full timeUltradent, a global name in oral health, is looking for a A/RA Stability Engineering Manager to join our team · The QA/RA Stability Engineering Manager is responsible for managing stability engineering activities for the organization. This includes supporting stability activities ...
-
Engineering Manager
2 weeks ago
Care Salt Lake City, United StatesJob Description · Job Description is a consumer tech company with heart. We're on a mission to solve a human challenge we all face: finding great care for the ones we love. We're moms and dads and pet parents. We have parents and grandparents, so we understand that everyone, at s ...
-
Engineering Manager
3 weeks ago
CARE Salt Lake City, United Statesis a consumer tech company with heart. We're on a mission to solve a human challenge we all face: finding great care for the ones we love. We're moms and dads and pet parents. We have parents and grandparents, so we understand that everyone, at some point in their lives, could us ...
-
Manager, Manufacturing Engineering
3 weeks ago
L3 Technologies Salt Lake City, United StatesJob Title: Manager, Manufacturing Engineering · Job ID: 10712 · Job Location: Salt Lake City, UT · Job Schedule: 9/80, 1st shift · Job Description: · The Manager, Manufacturing Process Engineering is responsible for technical and administrative leadership of a Manufactur ...
-
Electrical Engineering Manager
18 hours ago
GE Healthcare Salt Lake City, United StatesJob Description Summary · This leader will be based in our Salt Lake City facility where we design C-Arm machines used in a variety of surgical settings. · As part of the Engineering organization, the Electrical Engineering Manager has comprehensive responsibility for supervisi ...
-
Manager, Manufacturing Engineering
1 week ago
Harris Geospatial Solutions Salt Lake City, United StatesJob Title: Manager, Manufacturing Engineering · Job ID: 10712 · Job Location: Salt Lake City, UT · Job Schedule: 9/80, 1st shift · Job Description: · TheManager,Manufacturing Process Engineeringis responsible for technical and administrative leadership of a Manufacturing Process ...
-
Manager of Manufacturing Engineering
1 week ago
Easton Technical Products Salt Lake City, United StatesSince its beginnings in 1922, Easton Archery has focused on offering innovative, high-quality products that enhance the end-user's sporting experience. Easton revolutionized the sport of archery by introducing straight, consistent aluminum arrows in the 1940s, and has been the wo ...
-
Quality Engineering Manager
8 hours ago
Safeguard Global Recruiting Salt Lake City, United StatesQuality Engineering Manager · Salt Lake City · About Us: Join our rapidly growing medical device design house and manufacturing facility, where innovation and dedication to high-quality products drive our success. Our energetic team is committed to exceeding customer and patien ...
-
Manager, Software Engineering
2 weeks ago
Circle Salt Lake City, United StatesCircle is a financial technology company at the epicenter of the emerging internet of money, where value can finally travel like other digital data · globally, nearly instantly and less expensively than legacy settlement systems. This ground-breaking new internet layer opens up ...
-
Project Engineer Manager
2 weeks ago
Albany International Salt Lake City, United StatesAlbany Engineered Composites (AEC) is one of the most technically advanced designers and manufacturers of lightweight composite aerospace structures, subassemblies and components. For more than 50 years, AEC has innovated advanced composite solutions for defense and commercial in ...
-
Manager of Manufacturing Engineering
4 days ago
Easton Technical Products Salt Lake City, United StatesSince its beginnings in 1922, Easton Archery has focused on offering innovative, high-quality products that enhance the end-user's sporting experience. Easton revolutionized the sport of archery by introducing straight, consistent aluminum arrows in the 1940s, and has been the wo ...
-
Configuration Management Engineers
3 weeks ago
Azimuth Salt Lake City, United StatesCareer Opportunities with Azimuth Corporation · Careers At Azimuth Corporation · Share with friends or Subscribe · Current job opportunities are posted here as they become available. · Azimuth Corporation is seeking · Configuration Management Engineers , in support of an Air For ...
-
Manager, Software Engineer
2 weeks ago
MasterCard Salt Lake City, United StatesOur PurposeWe work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial ...
-
Manager of Manufacturing Engineering
2 weeks ago
Easton Technical Products Salt Lake City, United StatesJob Description · Job Description · Since its beginnings in 1922, Easton Archery has focused on offering innovative, high-quality products that enhance the end-user's sporting experience. Easton revolutionized the sport of archery by introducing straight, consistent aluminum ar ...
-
Project Engineering Manager
6 days ago
The Haskell Company Salt Lake City, United StatesOverview: · Are you ready to move your career forward, and start the BEST job of your life? Haskell is committed to providing you with the resources to help you grow and discover your potential. We promote an environment that encourages innovative ideas and allows you to develop ...
-
Manager, Software Engineering
1 week ago
Sunrun Salt Lake City, United StatesEverything we do at Sunrun is driven by a determination to transform the way we power our lives. We know that starts at the individual employee level. We strive to foster an environment you can thrive in through our commitment to diversity, inclusion and belonging. · Overview · ...
-
Manager of Manufacturing Engineering
2 weeks ago
Easton Technical Products Salt Lake City, United StatesJob Description · Job DescriptionSince its beginnings in 1922, Easton Archery has focused on offering innovative, high-quality products that enhance the end-user's sporting experience. Easton revolutionized the sport of archery by introducing straight, consistent aluminum arrows ...
-
Sr. Mobile Software Engineering Manager
2 days ago
Care Salt Lake City, United StatesAbout · is a consumer tech company with heart. We're on a mission to solve a human challenge we all face: finding great care for the ones we love. We're moms and dads and pet parents. We have parents and grandparents so we understand that everyone, at some point in their lives, ...
Quality Engineering Manager - Salt Lake City, United States - Safeguard Global Recruiting
Description
Quality Engineering Manager
Salt Lake City
About Us: Join our rapidly growing medical device design house and manufacturing facility, where innovation and dedication to high-quality products drive our success. Our energetic team is committed to exceeding customer and patient expectations through superior product quality and reliability.
Position Overview: We are seeking a Quality Engineering Manager to lead our team of skilled engineers in delivering top-notch medical devices. This role is pivotal in integrating quality throughout our manufacturing processes, ensuring our products consistently meet the highest standards. As a leader, you will foster a culture of continuous improvement, regulatory compliance, and customer satisfaction.
Key Responsibilities:
Qualifications:
Why Join Us: