1. Monitor and maintain stock levels and ships sales literature and sample requests to sales representatives and/or accounts from Monrovia supplies to support field sales efforts.$28k-39k yearly est.20d ago
Product Development Engineer
Responsible for producing product development documentation in accordance with Good Documentation Practice.$90k-119k yearly est.10d ago
Validation Quality Engineer II (Medical device)
1. Coordinate quality engineering activities to achieve business objectives.
2. Initiate and lead the development /review of validation policies, master plans and schedules, and protocols and quality engineering issues.
3. Support site production and engineering functions in process quality improvement activities.
4. Support the internal and supplier audit processes. This includes, but is not limited to, preparation of audit schedule and audit assignments, training auditors, conducting audits, and monitoring the performance of the audit process, as appropriate. Perform internal and/or supplier audits as required.
5. Support the risk documentation process, ensuring that product FMEAs, Hazard assessments, etc. are regularly updated as required.
6. Initiate and lead investigations involving manufacturing nonconformances, product or component failures, customer complaints, or product returns by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA/SCRs.
7. Interface with external auditors (Notified Body, FDA, etc.) during audits at STAAR sites; participate in the preparation and completion of corrective action plans as needed.
8. Apply statistical methodologies, risk analyses and other quality engineering tools to manufacturing and design related issues.
9. Coordinate contractor qualification activities with appropriate departments.
10. Compile Quality metrics, analyze trends and report to Quality Management.
11. Initiate and lead design process characterization studies (DOE, R&R); conduct statistical analysis of results to identify critical parameters and improves process capability.
12. Participate in Design Control on New Product development teams; advise the team on design control requirements; develop, review and approve design control deliverables related to quality engineering and validations.
13. Perform additional duties as assigned by Management.
EDUCATION & TRAINING
• Bachelor's degree, preferably in Engineering or sciences or equivalent combination of education/experience.
• Advanced degree preferred.
EXPERIENCE
• Three years' experience in validation and/or quality engineering in the medical device or pharmaceutical industries, including the practical application of FDA Quality System Regulation and ISO 13485 with BA/BS; or minimum two years' experience with advanced degree.
• Experience in vision care or intraocular lens industry preferred.
• General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required.
• Applicant must be knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.
SKILLS
• Excellent project management, organization, writing, communication and presentation skills required.
• Ability to communicate in a wide variety of communication styles and to influence and build consensus across cross-functional groups.
• Must have strong written and oral communication skills.
• Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols will be required.
• Ability to format, trend and present information using basic quality tools (i.e., scatter plots, histograms, Pareto diagrams, flow charts, SPC, FMEA, Fault Tree Analysis).
• Ability to compile, analyze, graph, and compare data using standard statistical techniques (i.e., t-tests, ANOVA, linear regression analysis).
• Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
• Proficiency in written and spoken English required.
STAAR Surgical is an equal employment opportunity employer.$80k-107k yearly est.20d ago
Business Intelligence Developer
Study, analyze and understand business requirements in context to business intelligence. Continuous learner of new advancements, STAAR Surgical-specific technologies, system behavior and business processes as they relate to customer needs. As a Business Intelligence (BI) Developer within STAAR Surgical's Information Technology team, this individual plays a critical role working closely with the business and across the Information Technology organization defining, delivering, and supporting IT business solutions and supporting roadmaps. Applies their knowledge of business intelligence and analytics best practices, documentation, and technologies.$91k-123k yearly est.15d ago
Business Systems Solution Architect - Supply Chain Management
Provides cost effective business systems and applications analysis in support of the development and implementation of business applications. Understands impact of emerging business trends and their implications for STAAR Surgical and its customers. Expert knowledge of business systems processes within the medical device manufacturing industry, including Order-to-Cash (Order management, fulfillment, and warehouse mgmt. As a Business Systems Solution Architect within STAAR Surgical's Information Technology team, this individual plays a critical role working closely with the business and across the Information Technology organization defining, delivering and supporting IT business solutions and supporting roadmaps. Formulates and defines systems scope and objectives based on both end-user needs and a thorough understanding of business systems, applications and industry requirements.$126k-168k yearly est.20d ago
Advanced Manufacturing Technician II
1. Perform highly technical tasks in manufacturing of Implantable Lenses (ICL).
2. Follow all applicable SOPs including Production Control, Environmental Control, Good Documentation Practice and Work Instruction procedures. Legibly document process records on Device History Record Forms.
3. Consistently meet quality and productivity targets.
4. Perform ICL manufacturing tasks including lens cleaning, tumbling, hydration, autoclaving, terminal sterilization and packaging.
5. Perform ICL in-process inspection utilizing microscopes and in-situ Ophthalmic testing instruments.
6. Support engineering studies with equipment setup and test sample fabrication.
7. Identify non-conformance events, report non-conforming material or operation activities to supervisor for initiation of non-conformance records.
8. Support process improvement projects from manufacturing perspective. Identify potential process issues and process improvement opportunities.
9. Interact with engineers and employees from other departments and work in a team environment.
10. Other duties as assigned.
EDUCATION & TRAINING
• Must possess a high school diploma or general education diploma (GED) or equivalent combination of education/experience.
EXPERIENCE
• Minimum 4 years of experience in medical device manufacturing environment, including minimum 1 year of direct experience in ophthalmology industry, preferably IOL, ICL or Contact Lens manufacturing.
• Experienced in autoclave and steam sterilization process preferable.
• Highly skilled in in-process inspections utilizing microscopes and/or other measurement/inspection equipment preferred.
• Experience with an ISO 13485 or cGMP manufacturing environment.
• Being able to provide operational job training to other technicians.
SKILLS
• Proven competence handling precision components. Being able to handle ICLs in both dry phase and hydrated phase with production tools.
• Must be able to read, write, and speak English.
• Be able to communicate with co-workers at all levels.
• Must possess good manual dexterity, technical aptitude and ability to identify process problems.
• Ability to take direction from lead/supervisor and contribute to departmental goals.
• Adaptable to different operational tasks in a growing business environment.
• Being able to lift up to 20 lbs.
• Basic computer skills strongly preferred.
STAAR Surgical is an equal employment opportunity employer.$46k-57k yearly est.22d ago
Quality Engineer I - Chemistry
2 years as a quality engineer preferred. 10. Interface with external auditors (Notified Body, FDA, etc.) during audits at the Monrovia site; participate in the preparation and completion of corrective action plans as needed.$80k-107k yearly est.22d ago
Supply Chain Assistant
At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. The Supply Chain Assistant is responsible for performing supply chain projects as assigned by the Sr. Supply Chain Manager. Endologix develops and manufactures minimally invasive treatments for aortic disorders.$20-22 hourly7d ago
Sr. Program Manager
The Senior Program Manager manages the project office function of Endologix and facilitates cross functional projects. At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. Endologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease.$128k-178k yearly11d ago
Manager, Regulatory Affairs
Manages regulatory affairs communication, filing strategy, regulatory negotiation, submission development, query response development and other assigned activities for Endologix products. The role of the Regulatory Affairs Manager is to oversee the development and implementation of global regulatory strategies in conjunction with global RA staff. Endologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease.$104k-151.3k yearly37d ago
Regulatory Affairs Coordinator
The role of the Regulatory Affairs Coordinator is to provide regulatory compliance, regulatory submission, and other system support to the Endologix Regulatory Affairs department At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. * As requested by RA management, perform various administrative duties in support of the Endologix Regulatory Affairs department including, but not limited to: Endologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease.$53k-73.3k yearly37d ago
Sr. Regulatory Affairs Specialist
* Represents the Regulatory Affairs function in internal and external audits of the Endologix Quality System. Overview Endologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease. Overview: The Senior Regulatory Affairs Specialist represents the Regulatory Affairs function in assigned project teams and completes projects and tasks to established timelines to meet corporate objectives.$85k-123.3k yearly37d ago
Regulatory Affairs Specialist
The Regulatory Affairs Specialist is Responsible for regulatory affairs activities to assist in regulatory submissions, annual reports, and compliance activities, including internal and external audits. Endologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease.$65k-95k yearly37d ago
Manufacturing Associate II
At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. * Responsible for 100% compliance to Endologix Quality and Regulatory policies and adhere to Endologix Core Values. The Manufacturing Associate II is responsible for assembling high quality medical devices in accordance with approved manufacturing process instructions and Standard Operating Procedures, assisting in the evaluation and resolution of line issues, and suggesting possible method / process improvements. Endologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease.$19-26 hourly11d ago
Senior Advanced Analytics Manager
At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. The Senior Manager will champion strategic vision, drive the analytics product development process, and foster strong relationships across functional areas. + Knowledge of Medtronic products and corporate structure The Senior Manager for Data Analytics and Insights is responsible for providing leadership and technical guidance to a team of Subject Matter Experts (SMEs), Analytic Product Owners and Data Analysts.$102k-124k yearly est.3d ago
Principal Remote Sales Representative
At Medtronic Cardiac and Vascular Group (CVG) we're committed to forging new paths and partnerships that help healthcare systems improve clinical outcomes, expand access to care , and optimize operational efficiencies. * Remotely sells Medtronic's CVG products and retains end-user patients within an assigned geographic area and /or specific customer accounts for pre-defined territory locations to achieve or exceed assigned sales goals. The CVG Remote Sales rep sells Medtronic's Cardiac and Vascular Group products remotely & retains end-user patients within an assigned geographic area and/or specific customer accounts for pre-defined territory locations in this office-based role. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. The physical demands described within the Responsibilities section of this job description are representative of those that must be m$64k-82k yearly est.3d ago
Credit Services Representative (USA/Remote)
Medtronic walks the walk, creating an inclusive culture where you can thrive. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.$39k-47k yearly est.3d ago
Associate Analyst, Product Solutions and Order Operations - Remote (FL, MA, MN, TN)
The Associate Analyst is a vital role responsible for providing primary support to the field sales staff in the areas of inventory optimization, obsolescence management, and order fulfillment across multiple businesses.$54k-73k yearly est.8d ago
Business Systems Solution Architect - Finance
Responsible for managing STAAR Surgical's Enterprise Applications, including: As Business Systems Solution Architect - Finance within STAAR Surgical's Information Technology team, this individual plays a critical role working closely with the business and across the Information Technology organization defining, delivering and supporting IT technical solutions and supporting roadmaps.$126k-168k yearly est.20d ago
Principal Advanced Analytics Analyst
At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.$97k-115k yearly est.3d ago
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Endologix may also be known as or be related to ENDOLOGIX INC DE, Endologix, Endologix Inc, Endologix LLC and Endologix, Inc.