Senior Supervisor, Quality

Posted 10 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
108K-153K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Lead and supervise quality inspection teams across multiple production areas, manage non-conformances and investigations, partner with Manufacturing/Engineering/Supply Chain, drive improvement projects and product transfers, own inspection procedures and production metrics, and ensure compliance with GMP, SOPs, and safety requirements.
Summary Generated by Built In

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 Quality Senior Supervisor leads our Quality Inspection teams in Components, Tissue, Solutions, Preliminary Packaging, and Valve Assembly areas of the Irvine Implant Manufacturing facility. The role provides oversight for daily operations, non-conformance management, and new product transfers, partnering closely with Manufacturing, Engineering and Supply Chain.
How you'll make an impact:
• Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality /technical knowledge of - multiple production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues, providing feedback, all hire/fire authority, and partnering with HR on all aspects of employee of employee.
• Lead complex improvement projects, partner with engineering on investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assures documentation content is valid.
• Provide regular progress reports and manufacturing metrics to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement while accountable for productivity and quality metrics of staff.
• Establish the scheduling of work orders and team performance metrics, including monitoring output and adjusting schedules to ensure production targets are achieved.
• Document owner for assigned product line inspection procedures.
• Responsible for all project outcomes of assigned unit/group of employees.
• Other incidental duties.

What you'll need:
• Bachelor's Degree in-depth technical knowledge and experience in assigned work area, and substantial experience in related manufacturing, quality and/or product development engineering, with skill levels exceeding the requirements of the Supervisor II or equivalent work experience based on Edwards criteria

• 4 years previous related experience with full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations in manufacturing, quality and/or product development engineering or equivalent work experience
What else we look for:
• Ability to supervise, lead, and/or mentor employees in a fast-paced manufacturing environment with experience fostering multi-cultural teams with cultural sensitivity.
• Proven expertise in both Microsoft Office Suite and Enterprise Resource Planning (ERP) system, preferably JDE.
• Experience working in a medical device industry, preferred.
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives, enhance job expertise and awareness of company policies for GMP, SOP and safety regulations, as well as mediating and negotiating the needs of other areas to achieve consensus.
• Full understanding of all aspects of processes and equipment used across areas of responsibility.
• Ensure testing conforms to appropriate standards of identity, strength, and quality of components and in process products.
• Knows and effectively uses fundamental concepts, practices, and procedures relative to quality and productivity improvements.
• Must be able to develop creative solutions to challenging problems; adept and experienced problem solver who is capable to determine root cause of technical issues and implements effective solutions in a timely manner
• Able to understand statistics, engineering drawings, Bills of Materials, and operational procedures.
• Knowledge of Lean Manufacturing concepts, SPC, Process Map, DFMEA/PFMEA and Six Sigma.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $108,000 - $153,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.  


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

Skills Required

  • Bachelor's degree with in-depth technical knowledge and relevant manufacturing/quality/product development experience
  • Minimum 4 years related experience with full personnel responsibility including hire/fire authority and employee relations in manufacturing or quality
  • Supervisory experience leading and mentoring employees in a fast-paced manufacturing environment
  • Proven expertise with Microsoft Office Suite
  • Experience with Enterprise Resource Planning (ERP) systems
  • Experience with JDE (JD Edwards)
  • Experience in the medical device industry
  • Knowledge and adherence to GMP, SOP, and safety/environmental regulations
  • Knowledge of Lean Manufacturing concepts, SPC, Process Mapping, DFMEA/PFMEA, and Six Sigma
  • Ability to understand statistics, engineering drawings, Bills of Materials, and operational procedures
  • Strong communication, interpersonal and cross-functional collaboration skills
  • Proven problem-solving skills, root-cause analysis, and corrective action implementation
  • Ability to schedule work orders, monitor production metrics, and be accountable for productivity and quality metrics

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Healthcare Strength Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
  • Retirement Support A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.

Edwards Lifesciences Insights

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The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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