Senior Manager, Quality Engineering

2 weeks ago

Salt Lake City, United States Edwards Lifesciences Full time

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. This Senior Manager will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. This role is critical to the success our advanced catheters manufacturing portfolio, where this senior manager will play a key role in the receipt of new product designs, manage a team to develop the manufacturing & inspection processes, guide the transfer of the process into production, and manage the production team that will scale up for production. The senior manager position is unique in that there is responsibility over the NPD process and the production process of the key products for our life-saving delivery systems.

How you will make an impact

: Manage the timeliness and effectiveness of highly complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes in the advanced catheters manufacturing area. Oversee the development of multiple, highly complex manufacturing processes and inspection methods and ensure that they are compliant with quality system requirements. Create strategies to manage the resources and execution of creating and validating new manufacturing processes (including evaluation of source materials and suppliers) and inspection methods based on engineering principles. Create strategies for resourcing and planning of design transfers from R&D to NPD, and process transfers from NPD to production. Plan and support the execution of optimization opportunities of new manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) that support design for manufacturing within the NPD framework. Plan and support continuous improvement projects within the production framework, including opportunities for re-design/design of highly complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk to patients. Review and approve technical content of risk management files, changes to quality documents, NCRs, training plans, validation reports, etc. Develop skills and capabilities of your team, discuss career goals, create goals and objectives to support career path discussions. Train new hires on documentation, investigation, and corrective actions for NCRs, CAPAs, and quality plans. Prepare material for quality data reviews and present to leadership regularly. Collaborate with cross-functional teams to lead implementation of corrective actions, employee support, product containment, quality system improvements, and improved training strategies. Support internal/external audits of processes, documentation, training records, including coordination of audit activities and presentation of evidence. Manage workload and training of your team.

What you’ll need: Bachelor's degree in Engineering or Scientific field plus a minimum of 8 years of experience within Quality, Manufacturing, or R&D; OR Master's degree in Engineering or Scientific field plus 7 years of experience within Quality, Manufacturing, or R&D required; or PhD in Engineering or Scientific field plus 4 years of experience within Quality, Manufacturing, or R&D. Minimum of 3 years of experience managing people Minimum of 4 years of experience working in a regulated industry Experience and strong knowledge of quality systems and manufacturing principles Demonstrated experience leading and executing validations (i.e. OQ/PQ) and quality actions (i.e. NCR, CAPA) Proven experience leading cross-functional project teams.

What else we look for: Engineering degree Management experience of quality engineers in medical device manufacturing Demonstrated ability and experience creating, executing, and monitoring corrective actions. Proven experience utilizing statistical analysis capabilities. Experience in goal setting, monitoring, and execution to plan. Ability to manage competing priorities in a fast-paced environment and manage expectations. Highly driven and accountable, track record of good decision making. Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards) . Experience with Six Sigma concepts (DMAIC preferred) with the ability to lead projects utilizing these principles. 6 sigma black belt certified. Certified quality engineer. Experience in external audits by notified agencies. Demonstrated track record in facilitating process improvement activities and conflict resolution. Ability to mentor and guide less seasoned engineers in resolving complex issues in specialized area based on existing solutions and procedures. Proficient in Microsoft Office Suite and related tools and systems.

#J-18808-Ljbffr

  • Quality Engineer III

    2 weeks ago

    Salt Lake City, United States bioMérieux SA Full time

    Description Position Summary This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be working with BioFire employees outside of Quality Assurance on a day-to-day basis...

  • Sr. Quality Engineer

    1 week ago

    Salt Lake City, United States PPC Flex Full time

    Job Description Job Description Job Summary: The Senior Quality Engineer will provide experienced quality assurance support to the product development team, resolving bugs, defects, and other issues and ensuring the product meets customer specifications. Responsibilities: Perform in-process and new product verification and validation activities. Address all...

  • Quality Engineer III

    2 weeks ago

    Salt Lake City, United States BioFire Diagnostics Full time

    Position Summary This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be working with BioFire employees outside of Quality Assurance on a day-to-day basis and must have...

  • Quality Systems Engineer

    1 hour ago

    Salt Lake City, United States Meet Recruitment Full time

    CSV/Data Integrity Analyst/Engineer or Quality Systems Engineer : Full-time position, newly-created due to need. Primary function will be identifying gaps in their computer systems that need validated. A Senior CSV Consultant will be training/upskilling this position. Help drive projects forward. Will be working for on the data integrity side, but is...

  • Quality Engineer III

    2 weeks ago

    Salt Lake City, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description Position Summary This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be working with BioFire employees outside of Quality Assurance on a day-to-day basis...

  • Quality Systems Engineer

    3 days ago

    Salt Lake City, United States Meet Full time

    CSV/Data Integrity Analyst/Engineer or Quality Systems Engineer: Full-time position, newly-created due to need. Primary function will be identifying gaps in their computer systems that need validated. A Senior CSV Consultant will be training/upskilling this position. Help drive projects forward. Will be working for on the data integrity side, but is...

  • Quality Systems Engineer

    24 hours ago

    Salt Lake City, United States Meet Full time

    CSV/Data Integrity Analyst/Engineer or Quality Systems Engineer: Full-time position, newly-created due to need. Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below. Primary function will be identifying gaps in their computer systems that need validated. A Senior CSV Consultant will be...

  • Quality Systems Engineer

    2 weeks ago

    Salt Lake City, United States Meet Full time

    CSV/Data Integrity Analyst/Engineer or Quality Systems Engineer:Full-time position, newly-created due to need.Primary function will be identifying gaps in their computer systems that need validated.A Senior CSV Consultant will be training/upskilling this position.Help drive projects forward.Will be working for on the data integrity side, but is considered a...

  • Quality Systems Engineer

    2 weeks ago

    Salt Lake City, United States Meet Full time

    CSV/Data Integrity Analyst/Engineer or Quality Systems Engineer:Full-time position, newly-created due to need.Primary function will be identifying gaps in their computer systems that need validated.A Senior CSV Consultant will be training/upskilling this position.Help drive projects forward.Will be working for on the data integrity side, but is considered a...

  • Quality Systems Engineer

    2 weeks ago

    Salt Lake City, United States Meet Full time

    CSV/Data Integrity Analyst/Engineer or Quality Systems Engineer:Full-time position, newly-created due to need.Primary function will be identifying gaps in their computer systems that need validated.A Senior CSV Consultant will be training/upskilling this position.Help drive projects forward.Will be working for on the data integrity side, but is considered a...

  • Quality Engineer III

    2 weeks ago

    Salt Lake, Utah, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description Position Summary This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be working with BioFire employees outside of Quality Assurance on a day-to-day basis...

  • Senior Engineer, Validations

    2 weeks ago

    Salt Lake City, United States DISCGENICS INC Full time

    Job DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary:  The Senior Validations Engineer will fill an important need at DiscGenics through helping the...

  • Senior Project Geotechnical Engineer

    3 days ago

    Salt Lake City, United States AECOM Full time

    Job Description Make your application after reading the following skill and qualification requirements for this position.As an AECOM Senior Project Geotechnical Engineer, you will work with our Salt Lake City geotechnical group, as well as interdisciplinary groups from Salt Lake City and other offices, to deliver consulting services on rewarding...

  • Quality Engineer I

    2 weeks ago

    Salt Lake, Utah, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description This is a full-time exempt position. The Quality Engineer I is responsible for assisting with the maintenance of technical aspects of the Quality Management System, including investigations, validations, corrective actions, risk management, and continuous improvement efforts. This person will be working with BioFire employees outside of Quality...

  • Senior Project Manager

    3 weeks ago

    Salt Lake City, United States Grnslc Full time

    Senior Project Manager & Estimator Salt Lake City, UT Required Experience: BS Civil Engineering or EE EV Electrical Vehicle Required Education: BS Job Description Seeking a highly experienced and skilled construction professional with a background in civil or electrical engineering for the role of Senior Project Manager/Estimator. This individual will be...

  • Quality Engineer I

    3 weeks ago

    Salt Lake City, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description This is a full-time exempt position. The Quality Engineer I is responsible for assisting with the maintenance of technical aspects of the Quality Management System, including investigations, validations, corrective actions, risk management, and continuous improvement efforts. This person will be working with BioFire employees outside of Quality...

  • Senior Program Manager

    3 weeks ago

    Salt Lake City, United States Coda Octopus Colmek Full time

    Full Listing Career Growth Opportunity Seeking an experienced, high-energy senior program manager to join our leadership team as we enter a new phase of growth in our DOD-focused business. The Sr. Program Manager will provide leadership and direction for our Department of Defense programs, and actively manage all new engineering development programs and...

  • Senior Engineer

    7 days ago

    Salt Lake City, United States Qualus Power Services Corp Full time

    Position Overview Power your future with Qualus as a Senior Substation Engineer. Substation Design Engineers are responsible for designing substations utilizing applicable codes and client standards (if available). Typical design to include general arrangement, equipment and electrical layout, elevation views, cable trench, grounding, conduit drawings,...

  • Senior Mobile Engineering Manager

    4 weeks ago

    Salt Lake City, United States Traeger Wood Pellet Grills Full time

    Job DescriptionJob DescriptionWelcome To The Traegerhood: Our business is BBQ, and business tastes good. Traeger invented the wood pellet grill over 30 years ago, and we've been revolutionizing outdoor cooking ever since. We're a team of disruptors, innovators, problem solvers, and food fanatics who are dedicated to bringing people together to create...

  • Quality Engineer

    2 weeks ago

    Salt Lake City, United States Hammon Plating Full time

    Job DescriptionJob DescriptionQuality Engineer                                                                                                         Family owned Hammon Plating has been in business since 1969. As a leader and critical supplier in the cleaning and...