Location
USA - California – Irvine
Compensation
$51k–$70k USD
Type
full time
Posted
Yesterday
Market range · company + function + seniority
p25 · target · p75 · n=11
Posted $70k · well below market
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Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.
Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.
How you'll make an impact:
• The standard hours for this role are Monday-Friday 5:30am-2:00pm.
• Performing visual, dimensional, and functional inspection across all components and/or finished medical device products using a wide variety of all applicable tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications - working independently at the highest levels of productivity.
• Performing functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications.
• Reviewing, following and performing job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.
• Performing verification of manufacturing documents with component and device drawings, which may include Geometric Dimensioning and Tolerancing methodologies.
• May control inventory to ensure appropriate storage conditions and movement.
• Other incidental duties assigned by leadership: Train colleagues from other sites, including inspection of their work. Provide coaching and training to lower level employees, evaluate and demonstrate correct approach on work of other employees, able to fill-in for Lead as needed. On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
What you'll need (Required):
• 4 years related experience required.
• Basic computer skills required, including working knowledge of manufacturing software.
• Due to the specific duties of this job, you must be able to read, comprehend, write, and speak English.
What else we look for (Preferred):
• HS Diploma preferred.
• Ability to use applicable tools and equipment, hand eye coordination, and high manual dexterity.
• Strong communication skills and interpersonal relationship skills, including ability to convey training in methodology and procedures.
• Full understanding of applicable inspection procedures, including the ability to contribute to the development of procedures.
• Proficient in all inspection techniques for production inspection.
• Ability to clearly describe and convey nonconformance issues, and enter them into QMS.
• Ability to program and contribute to the validation of automated test equipment.
• Strict attention to detail.
• Must be able to work in a team environment and with minimum supervision by following detailed work instructions.
• Propose modifications to work assignments and/or station set-ups to maintain smooth workflow.
• Able to fill-in for Lead as needed.
• Ability to effectively provide and accept feedback from colleagues.
• Provide feedback on product defects and may follow through to establish resolution.
• 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 $51,000 to $70,000 (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.