Top 54 Regulatory affairs lead Jobs in Utah

Principal Supplier Quality Engineer, New Product Development
Edwards Lifesciences —Salt Lake City, UT
- Full-time
- 5 years
- Engineering
- Master's degree
Research Security & Export Control
University of Utah —Salt Lake City, UT
- $110,000 - $170,000 a year
- Online Application
- Master's degree
- University
- Bachelor's degree
SANITATION SUPERVISOR
Premium Production —Hildale, UT
- $24.50 - $35.00 an hour
- 8 hour shift
- Google Workspace
- Writing skills
- Mid-level
- Paid parental leave
- Health savings account
Quick Apply
Quality Engineer
Entegee —Salt Lake County, UT
- $50 - $60 an hour
- Contract
- 5 years
- Engineering
- Fair chance
- Commuter assistance
- Disability insurance
Quick Apply
Sr. Global Market Manager, Molecular
bioMerieux —Salt Lake City, UT
- $121,200 - $181,700 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- Marketing
- Office
- Commuter assistance
- Disability insurance
Strategy & Platform Program Manager
Tesla —Draper, UT
- Full-time
- 5 years
- System design
- Senior level
- Commuter assistance
- Health savings account
11d
Community Clean Energy Program Manager
Pacificorp —Salt Lake City, UT
- $102,000 - $140,250 a year
- Background check
- Oracle
- Microsoft Outlook
- Paid parental leave
- Disability insurance
Specialty Business Manager, Derm - Salt Lake City S, UT
Takeda Pharmaceutical —Utah
- $63.51 - $87.31 an hour
- Full-time
- Remote
- Private practice
- Hospital
- Bachelor of Science
- Paid holidays
- Disability insurance
Product Manager
Caldera Medical —Park City, UT
- Full-time
- 5 years
- Bachelor of Science
- Office
- Paid parental leave
- AD&D insurance
Quick Apply
Regulatory Permitting Specialist
Rainmaker Technology Corporation —Salt Lake City, UT
- $100,000 - $120,000 a year
- Bachelor's degree
- Continuous improvement
- Travel
Quick Apply
Product Compliance & Regulatory Affairs Manager
Pestie —Bluffdale, UT
- Full-time
- 5 years
- Office
- Analysis skills
- Relocation assistance
- Dental insurance
Quick Apply
Director, HR MDS
BD —Salt Lake City, UT
- Bachelor of Science
- Office
- Travel
Sr. Global Market Manager, Molecular
bioMérieux —Salt Lake City, UT
- $121,200 - $181,700 a year
- Hybrid work
- Microsoft Outlook
- Marketing
- Office
- Commuter assistance
- Disability insurance
Quick Apply
Research Security & Export Control
University of Utah Health —Salt Lake City, UT
- $110,000 - $170,000 a year
- Full-time
- Pass drug screening
- Master's degree
- University
- Retirement plan
Clinical Project Manager - Oncology (Client Dedicated/Remote)
サイネオス・ヘルス —Utah
- $120,000 - $135,000 a year
- Remote
- Mid-level
- 3 years
- Bachelor's degree
- Employee stock purchase plan
- Health insurance
Vice President, Strategic Engagement
Western Electricity Coordinating Council —Salt Lake City, UT
- Hybrid work
- Up to 50% travel
- Marketing
- Computer literacy
- Health insurance
- Dental insurance
Quick Apply
CAPA Process Lead
Varex Imaging —Salt Lake City, UT
- Full-time
- 5 years
- Engineering
- Senior level
- Paid parental leave
- Employee stock purchase plan
Quality Assurance and Regulatory Compliance Specialist
OrthoSelect —American Fork, UT
- $30 - $40 an hour
- Full-time
- 3 years
- Project management
- Bachelor's degree
- Paid holidays
- 401(k)
Quick Apply
9d
Director of Quality
Biotron Laboratories, Inc —Ogden, UT
- $120,000 - $135,000 a year
- Full-time
- Master's degree
- Recruiting
- In-person
- Health savings account
- Health insurance
Quick Apply
Product Sr Manager
Zimmer Biomet —Salt Lake City, UT
- $140,000 - $165,000 a year
- Full-time
- Marketing
- Bachelor of Science
- Product management
- Wellness program

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Principal Supplier Quality Engineer, New Product Development

Edwards Lifesciences -
Salt Lake City, UT

Apply Now

Job Details

Full-time

Qualifications

Hypothesis testing
Team leadership
Quality control statistical data analysis
Coaching
Statistical Process Control
Statistical analysis
Inferential statistics
Mentoring
Managing projects
Monitoring processing parameters
Statistical significance testing

Full Job Description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Principal Supplier Quality Engineer will mentor engineers & technicians; provide direction and oversight of supplier quality activities; and play a key role leading critical projects that support our COE (Center of Excellence) for Metals and Advanced Catheter Delivery System. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Marketing, Sourcing, Supplier Development Engineering and Receiving Inspection. This engineer will not only manage stakeholder relationships but also lead successful parts qualification efforts with external suppliers to support product development and commercial launch timelines for innovative and life-saving medical devices. The engineer will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

How you will make an impact :

Lead complex, medium-scale projects with significant business impact, ensuring successful delivery of all milestones. Develop and manage project plans, schedules, and quality objectives while applying engineering expertise to evaluate and improve supplier designs and processes for new to market devices and novel technologies.
Lead root cause investigations of complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations and findings, etc.) related to supplier manufacturing processes.
Lead the development and execution of complex experiments and test methods (including writing and executing protocols) to validate and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods.
Lead deliverables specific to component engineering per the Product development process including concept, early human use, clinical and commercialization phases while ensuring high standards for quality compliance and product safety.
Ensure the optimization of complex internal and supplier manufacturing processes using engineering methods (e.g., Six Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and industry best practices.
Develop technical content of risk management files.
Develop training and documentation materials on component test methods for Receiving Inspection (e.g., test method procedures, inspection routers, etc.).
Conduct on-site supplier audits.
Provide training, coaching, and mentorship to engineers on Supplier Quality procedures and responsibilities.

What you’ll need (Required):

Bachelor's degree with 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions; OR Master's degree with 5 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions
Well-versed in statistical tools such as Gage R&R, Statistical Process Control, Process Capability Studies, Hypothesis Testing, and other statistical techniques related to manufacturing.
Project Management Experience
Demonstrated leadership capabilities in coaching/guiding less seasoned engineers and teammates.
Highly regulated industry experience
Ability to work 100% onsite at our Draper, UT location. This role is not eligible for remote or hybrid work arrangements
Must have ability to travel up to 20%.

What else we look for (Preferred) :

Engineering degree
Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
Experience with CAPAs, NCRs, Change Notifications, and/or Auditing.
Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
Experience creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs).
In-depth knowledge of manufacturing process for shaft manufacturing, injection molding and extrusions.
Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices.
Six Sigma Green or Black Belt Certified.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Apply Now

Refine Your Search

regulatory affairs lead jobs in utah

Principal Supplier Quality Engineer, New Product Development

Research Security & Export Control

SANITATION SUPERVISOR

Quality Engineer

Sr. Global Market Manager, Molecular

Strategy & Platform Program Manager

Community Clean Energy Program Manager

Specialty Business Manager, Derm - Salt Lake City S, UT

Product Manager

Regulatory Permitting Specialist

Product Compliance & Regulatory Affairs Manager

Director, HR MDS

Sr. Global Market Manager, Molecular

Research Security & Export Control

Clinical Project Manager - Oncology (Client Dedicated/Remote)

Vice President, Strategic Engagement

CAPA Process Lead

Quality Assurance and Regulatory Compliance Specialist

Director of Quality

Product Sr Manager

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