Sonova USA, Inc.
Change Control and Labeling Analyst
Sonova USA, Inc., Santa Clarita, California, United States, 91382
Who we areYou enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life's unforgettable moments.We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.If you want the freedom to explore, opportunities to grow, and make positive change on people's lives through your work, this is the place for you.Join Sonova. Create sense.Position:
Change Control and Labeling Analyst (Hybrid)The Change Control and Labeling Specialist position is responsible for timely research, analysis, and processing of complete and accurate Change Orders in the Oracle Agile Product Lifecycle Management (PLM) system. The Change Control and Labeling Specialist will ensure changes comply with company procedure and regulatory requirements.The Change Control and Labeling Specialist's priorities will be focused on labeling, including labels, Information for Use (IFU), Bill of Material (BOM), and Engineering/Manufacturer Change Order (ECO/MCO).Responsibilities:Create, update, release and maintain lifecycle status of labels for AB globally in the PLM and SAP systems.Create, update, and test SAP ERP label templates; validate templates per AB Quality System protocol.Create verification and validation test cases for label testing.Execute verification and validation testing protocols for label testing.Execute research, analysis and processing of Engineering Change Orders (ECO) and Manufacturing Change Orders (MCO) timely and accurately using Oracle Agile PLM as a component of the Quality Management System.Activate, Inactivate and maintain user accounts in PLM.Train department personnel on Document Control systems, practice and procedure.Execute SolidWorks CAD drawing load verification and drafting; interprets engineering drawings and specifications.Create the Revision of record in the Camstar Manufacturing Execution System.Create and distribute daily documentation release reports to AB globally.Execute master data verification in SAP ERP following release of change orders.Update Manufacturing Routings in SAP ERP following release of change orders.Other duties assigned.Additional Requirements:Monitors quality control and measurements and ensures documentation.Supports more senior colleagues in analyzing department data results and providing feedback and interpretation.Maintains and organizes quality records in accordance with governing procedures and creates statistics of Key Performance Indicators or other metrics.Provides support and assists in internal and external audits to evaluate and monitor Sonova's processes and systems.Develops quality management related documents and policies.Travelling Requirement:
Up to 20%More about you:Education:High School Diploma or equivalent.Nice to Have:Bachelor's Degree.Work Experience:3-5 years Document Control experience.3-5 years in Class 3 medical device manufacturing in compliance with FDA 21CFR820, ISO 13485:2016, EU MDR.3-5 years of experience in executing Good Documentation Practices (GDP).Nice to Have:Document Control experience in Medical Device industry.Language(s)/ Level:English/ Fluent.IT Skills:Proficiency with Microsoft Office products Word, Excel and Adobe Acrobat writer.Nice to Have:Experience with PLM, SAP ERP.Experience with integration tools such as system portals, PLM system process extensions, add-ons/plug ins such as xEngine, CAD Utilities.Knowledge of interface functionality between systems such as PLM to SAP to Camstar.A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered.What we offer:Medical, dental and vision coverage*Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts.TeleHealth options.401k plan with company match*Company paid life/ad&d insurance.Company paid Short/Long-Term Disability coverage (STD/LTD).Accident/Hospital Indemnity coverage.Legal/ID Theft Assistance.PTO (or sick and vacation time), floating Diversity Day, & paid holidays*.Paid parental bonding leave.Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more).Robust Internal Career Growth opportunities.Tuition reimbursement.Hearing aid discount for employees and family.Internal social recognition platform.D&I focused: D&I council and employee resource groups.*Plan rules/offerings dependent upon group Company/location.This role's pay range is between: $29.23/hr - $43.85/hr. This role is also bonus eligible.How we work:At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.
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Change Control and Labeling Analyst (Hybrid)The Change Control and Labeling Specialist position is responsible for timely research, analysis, and processing of complete and accurate Change Orders in the Oracle Agile Product Lifecycle Management (PLM) system. The Change Control and Labeling Specialist will ensure changes comply with company procedure and regulatory requirements.The Change Control and Labeling Specialist's priorities will be focused on labeling, including labels, Information for Use (IFU), Bill of Material (BOM), and Engineering/Manufacturer Change Order (ECO/MCO).Responsibilities:Create, update, release and maintain lifecycle status of labels for AB globally in the PLM and SAP systems.Create, update, and test SAP ERP label templates; validate templates per AB Quality System protocol.Create verification and validation test cases for label testing.Execute verification and validation testing protocols for label testing.Execute research, analysis and processing of Engineering Change Orders (ECO) and Manufacturing Change Orders (MCO) timely and accurately using Oracle Agile PLM as a component of the Quality Management System.Activate, Inactivate and maintain user accounts in PLM.Train department personnel on Document Control systems, practice and procedure.Execute SolidWorks CAD drawing load verification and drafting; interprets engineering drawings and specifications.Create the Revision of record in the Camstar Manufacturing Execution System.Create and distribute daily documentation release reports to AB globally.Execute master data verification in SAP ERP following release of change orders.Update Manufacturing Routings in SAP ERP following release of change orders.Other duties assigned.Additional Requirements:Monitors quality control and measurements and ensures documentation.Supports more senior colleagues in analyzing department data results and providing feedback and interpretation.Maintains and organizes quality records in accordance with governing procedures and creates statistics of Key Performance Indicators or other metrics.Provides support and assists in internal and external audits to evaluate and monitor Sonova's processes and systems.Develops quality management related documents and policies.Travelling Requirement:
Up to 20%More about you:Education:High School Diploma or equivalent.Nice to Have:Bachelor's Degree.Work Experience:3-5 years Document Control experience.3-5 years in Class 3 medical device manufacturing in compliance with FDA 21CFR820, ISO 13485:2016, EU MDR.3-5 years of experience in executing Good Documentation Practices (GDP).Nice to Have:Document Control experience in Medical Device industry.Language(s)/ Level:English/ Fluent.IT Skills:Proficiency with Microsoft Office products Word, Excel and Adobe Acrobat writer.Nice to Have:Experience with PLM, SAP ERP.Experience with integration tools such as system portals, PLM system process extensions, add-ons/plug ins such as xEngine, CAD Utilities.Knowledge of interface functionality between systems such as PLM to SAP to Camstar.A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered.What we offer:Medical, dental and vision coverage*Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts.TeleHealth options.401k plan with company match*Company paid life/ad&d insurance.Company paid Short/Long-Term Disability coverage (STD/LTD).Accident/Hospital Indemnity coverage.Legal/ID Theft Assistance.PTO (or sick and vacation time), floating Diversity Day, & paid holidays*.Paid parental bonding leave.Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more).Robust Internal Career Growth opportunities.Tuition reimbursement.Hearing aid discount for employees and family.Internal social recognition platform.D&I focused: D&I council and employee resource groups.*Plan rules/offerings dependent upon group Company/location.This role's pay range is between: $29.23/hr - $43.85/hr. This role is also bonus eligible.How we work:At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.
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