Senior Supervisor, Quality

Posted 4 Days Ago
Be an Early Applicant
Irvine, CA
106K-149K Annually
Senior level
Healthtech • Pharmaceutical
The Role
The Senior Supervisor, Quality will oversee quality assurance activities in manufacturing, ensuring product safety and integrity. This role includes supervising staff, leading improvement projects, conducting performance reviews, ensuring compliance with quality standards, and collaborating with engineering teams. The supervisor will also manage documentation for inspection procedures and mentor entry-level supervisors.
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.

Supervise employees and activities across areas of quality for smooth and continuous operations.
How you'll make an impact:
• Supervising 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

• Leading complex improvement projects, partner with engineering on investigations and/or corrective actions, perform non-conformance investigations for review with management, assures documentation content is valid
• Providing 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
• Establishing the scheduling of work orders and team performance metrics, including monitoring output and adjusting schedules to ensure production targets are achieved
• Ensuring appropriate staffing for all positions
• Conducting performance reviews, including resolving performance issues
• Ensuring staff is appropriately trained to perform assigned work
• Documenting owner for assigned product line/area inspection procedures
• Quality compliance expertise with experience participating in internal/external audit activities including providing oral response to audit requests
• Responsible for all project outcomes of assigned unit/group of employees
• May guide and mentor entry level supervisors
• Other incidental duties
What you'll need (Required):
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 Required and
Other: 4 Years years experience 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 Required
What else we look for (Preferred):
• Experience leading and fostering multi-cultural teams with cultural sensitivity
• Proven expertise in both Microsoft Office Suite and Enterprise Resource Planning (ERP) system, preferably JDE

• Familiarity with use of Reliance EQMS system, preferred
• 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, as well as mediating and negotiating the needs of other areas to achieve consensus
• Full understanding of quality procedures while applying acquired expertise to analyze and solve problems without clear precedent
• Ability to supervise, lead, and/or mentor employees in a manufacturing environment
• Full understanding of all aspects of processes and equipment used across areas of responsibility
• Demonstrated ability to supervise teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee of employee
• Work with the Operation Quality Engineer, to develop professional skills to enhance job expertise and awareness of company policies for GMP, SOP and safety regulations. Oversee personal development plan and performance against plan.
• Ensure testing conforms to appropriate standards of identity, strength, and quality of components and in process products
• Complete understanding and wide application of principles, theories, and concepts in business area.
• An advanced understanding of specific aspects of work supervised and practical application to problems and situations ordinarily encountered
• 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
• Excellent working knowledge of statistics
• Able to understand engineering drawings, Bills of Materials, and operational procedures
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Lean Manufacturing concepts, SPC, Process Map, DFMEA/PFMEA and Six Sigma
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• 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 (CA), the base pay range for this position is $106,000 to $149,000 (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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

The Company
Draper, Utah
13,687 Employees
On-site Workplace
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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