Compliance Engineer, RAQA
4 weeks ago
Compliance Engineer, RAQA page is loaded Compliance Engineer, RAQA Apply locations Lund, Sweden time type Full time posted on Posted Yesterday job requisition id R518033 Work Flexibility: Hybrid Compliance Engineer, RAQA
Welcome to join the Stryker/Jolife AB team in Lund where we develop and manufacture the LUCAS chest compression system; a life-saving medical device invented in Lund and used by emergency care professionals all over the world to treat sudden cardiac arrest patients.
In your new role as Compliance Engineer you will ensure the organization maintains regulatory compliance for the quality system and the device, including the product environmental aspects. You will be Responsible for the Circulatory Business Regulatory Intelligence and the management for the evaluation of new and revised international safety standards, regulations, and others from initiation to completion.
As the local Subject Matter Expert for the Product Environmental Compliance you will be responsible to define, develop, and deploy environmental strategies, programs and systems to comply with international product environmental regulations, customer expectations, and company policies, initiatives and goals.
Opportunities & benefits that the role offersThis person will be exposed to our passion to develop emergency care solutions that are designed to help save lives.
Opportunity to work with fulfilling cross functional activities with colleague, both locally and internationally.
Help shape the future of the LUCAS device to ensure we provide best in class products to our customers.
Work in Europe’s 7th best “Great Place to Work”.
Attractive flexibility in working arrangements.
You have at least 4 years experience in the medical device, pharmaceutical or life science industry, preferably in a role where you have been exposed to applicable regulations, safety standards, product compliance and certifications. Product environmental compliance experience is a merit.
• Working knowledge with IEC standards for medical devices such as: IEC 60601 series / 62133-2 / IEC 62366-1 / ISO 14971 / ISO 13485
• Working knowledge with international regulations like: 21 CFR 820 / EU-MDR, RED / Low Voltage Directive 2014/35/EU (LVD) / SOR 98-282 / Australian Therapeutic Goods Act (TGA) / MHLW Ministerial Ordinance No. 169
• Working knowledge of regulations and best practices in the following areas: RoHS, REACH, WEEE, Battery, Packaging, and Proposition 65
You have a Bachelor’s Degree in Engineering, Science or other relevant field.
You speak Fluent Swedish and English A keypart of this role will be to work with international stakeholders across the world.
You are a Collaborative Partner with excellent interpersonal communication and collaborative teamwork skills, who thrives to work with team members at various levels of the organization and from different cultures.
You stay focused on the Goal You are self-directed and enjoys problem solving while staying focused on the goal. You can organize and understand the importance of keeping track of what is going on in your goals/projects.
You do the Right Thing You have a high level of integrity, responsibility, discipline, and attention to detail.
What will you do at Stryker?Lead the identification, assessment, monitoring, and implementation of applicable new or revised standards, regulations, directives, implementing decisions and common specifications to assure postmarket regulatory requirements are met
Evaluate the regulatory environment to assist in development of implementation strategies
Work with individuals and department managers to identify appropriate resources and schedules needed for implementation actions
Facilitate the Standard Review Board
Design, implement, and maintain quality system procedures for product environmental compliance
Plan, develop, implement, document, train, communicate and monitor compliance with international product environmental regulations and product compliance standards
Assist the business and design teams in understanding environmental requirements and necessary actions to achieve compliance.
Be responsible for verification that technical reports and required evidence documents exist at part and product level
Oversee and / or execute submission of required reports to the regulating authorities
Jolife AB, a wholly owned company by Stryker Inc, develops and markets the LUCAS Chest Compression System, with related accessories for the global market. LUCAS is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR).
Stryker Lund/Jolife AB is a part of Stryker corporation, an American global leading med tech company, listed on NYSE; a Fortune 500 company; with a solid track record of continuous growth and awarded for being a great place to work.
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spines that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more that 130 million patients annually. More information is available at stryker.com.
Travel Percentage: None #J-18808-Ljbffr-
Quantitative Risk Consultant
4 weeks ago
Sverige, Sweden FCG Risk & Compliance Oy Full timeDo you want to pursue an opportunity to take the next step in growing your career, knowledge, and network by working on exciting projects as a consultant in Quantitative Risk? Advisense Risk & Finance has been redefining the finance industry since 2008 and continues to grow. We are building a market-leading GRC (governance, risk, and compliance) practice in...
-
CSV Engineer
4 weeks ago
Sverige, Sweden Capgemini Full timeAre you passionate about and experienced in the field of validation and computerized systems? Join us and get the future you want! We are currently looking for a person specialized in the field of validation of computerized systems (CSV) to our newly formed Compliance Quality & Regulatory team in Gothenburg, where you will have the opportunity to...
-
Electrical Commissioning Engineer
4 weeks ago
Sverige, Sweden Winthrop Technologies Ltd Full timeWinthrop Technologies is a dedicated data centre delivery partner providing turnkey solutions to our clients, headquartered in Dublin and delivering throughout Europe. Winthrop specialises in providing turnkey data centre solutions, providing services from design, through to construction across the full range of civil, structural, architectural, mechanical...
-
System/Software Test Engineer
2 weeks ago
Sverige, Sweden Swediumglobal Full timeSystem/Software Test Engineer System/Software Test EngineerTasks:Software Qualification Testing: System/Software Test Engineers ensure that the integrated software meets the software requirements. They perform software qualification tests shortly before delivering the software to the customer or as a basis for the system. Key aspects include verifying...
-
Lead Engineer
3 weeks ago
Sverige, Sweden Northvolt AB Full timeAs the TecSa Lead, you will play a pivotal role in merging Technical Cleanliness and Industrial Engineering principles within the Skelleftea Gigafactory. Your primary responsibility is to conceptualise, design, deploy, maintain, and advance technical cleanliness standards across all Northvolt Ett processes and environments. This encompasses managing and...
-
Senior Process Safety Engineer
6 days ago
Sverige, Sweden Northvolt AB Full timeWe are looking for an experienced senior process safety engineer to join us in our mission to contribute to a greener future. The role is a part of our passionate CAM (Cathode Active Materials) team based in Skellefteå or Västerås. By joining us, you will be a key player in establishing CAM and contribute to building one of the first large scale European...
-
Construction Engineer
4 weeks ago
Sverige, Sweden Northvolt AB Full timeWe are looking for an experienced Construction Engineer focusing on rotating equipment to join us in our mission to contribute to a greener future. The role is a part of our excellent Cathode Active Materials team based in Skellefteå, Sweden. By joining us, you will be a key player in ramping up giga factory ett and contribute to building one of the first...
-
Instrumentation Engineer
4 weeks ago
Sverige, Sweden Northvolt AB Full timeWe are looking for an experienced Instrumentation Engineer to join us in our mission to contribute to a greener future. The role is a part of our excellent Instrumentation and Metrology team based in Skellefteå. By joining us, you will be a key player in contributing to building one of the first large scale European battery factories. About the job We...
-
Civil Underground
5 days ago
Sverige, Sweden Northvolt AB Full timeApplications are considered on a rolling basis We are looking for a talented intern who wants to be a part of the Civil, Structural, Architectural Northvolt design team developing and executing factories for the world’s greenest battery! In this role you will be a direct part of the Civil Underground Design Team for the Road, Paving and Underground...
-
Service Engineer · Consilium Canada
4 weeks ago
Sverige, Sweden Consilium Safety Group Full timeJoin Our Expanding Team as a Service Engineer At Consilium Safety Group, we are at the forefront of developing advanced fire and gas detection technologies for multiple sectors including the marine, energy, transport, and building industries. Founded in 1912 and with a global presence in over 55 countries, our mission is to safeguard lives, assets, and the...
-
System Engineer
4 weeks ago
Sverige, Sweden Stryker Corporation Full timeWelcome to join the Stryker/Jolife AB team in Lund where we develop and manufacture the LUCAS chest compression system; a life-saving medical device invented in Lund and used by emergency care professionals all over the world to treat sudden cardiac arrest patients. The System Engineer will be part of shaping the future for circulatory treatments and to...
-
Mechanical Commissioning Engineer
4 weeks ago
Sverige, Sweden Winthrop Technologies Ltd Full timeWinthrop Technologies is a dedicated data centre delivery partner providing turnkey solutions to our clients, headquartered in Dublin and delivering throughout Europe. Winthrop specialises in providing turnkey data centre solutions, providing services from design, through to construction across the full range of civil, structural, architectural, mechanical...
-
Maintenance Engineer REVOLT
4 weeks ago
Sverige, Sweden Northvolt AB Full timeWe are looking for a driven Maintenance Engineer to join us in our mission to contribute to a greener future. The role is a part of our passionate Maintenance team based in Skelleftea. As a Maintenance Engineer you will play an important role within the maintenance team of Revolt. Reporting directly to the maintenance manager, you will have a key role in...
-
Sverige, Sweden Downing Ventures Full timeDowning is a responsible investment manager founded in London in 1986. Our vision is to be a leader in our chosen markets, so that we can deliver attractive returns for investors by investing in assets and businesses that contribute to a better future. Find out more about our story . Downing Renewable Developments Downing Renewable Developments (DRD), is...
-
Production Engineer IKEA Food
6 days ago
Sverige, Sweden IKEA Gruppe Full timeCompany description Do you have passion for food? Would you like to be part of fantastic IKEA Food journey? Do you have a solid base in manufacturing and quality improvement methodologies within the food industry? Would you like a position where you will have a great impact on the way IKEA is working together with our Suppliers across the world? A position...
-
Factory planning
3 weeks ago
Sverige, Sweden Northvolt AB Full timeNorthvolt has an exciting job opening for an Engineer with experience in the field of Factory planning and Material Flow Automation (e.g., Automatic Storage and Retrieval Systems, Production-Buffers, Robots, AGVs, etc.) for the Drei Factory. By accepting this mission, you will take a key role in shaping Northolt’s Giga Factory in Heide to...
-
Software Quality Assurance Engineer
3 weeks ago
Sverige, Sweden SAAB Full timeWant to influence the bigger picture? At Saab, you can realise amazing innovations that keep people and societies safe. Together, we can truly make an impact – and your part matters. Your role You will be part of the Surface Sensor Solutions Quality Management team at Saab Surveillance. We are a mixed group where everybody's opinion is valued and...
-
Senior Solutions Engineer
4 weeks ago
Sverige, Sweden Quantexa Limited Full timeWhat we’re all about. Do you ever have the urge to do things better than the last time? We do. And it’s this urge that drives us every day. Our environment of discovery and innovation means we’re able to create deep and valuable relationships with our clients to create real change for them and their industries. It’s what got us here – and it’s...
-
ICT Architect
3 weeks ago
Sverige, Sweden Amm Group Full timeDesign of network and network security infrastructure (Firewalls, routers & switches…) - Build & maintain infrastructure Documentation Monitoring Spare & inventory, Capacity management… Additionally, Proven ability to act in a multi stakeholder environment (large network worldwide) - Ability to analyze and break down strategies into...
-
Inverter Designer
4 weeks ago
Sverige, Sweden RPS Softwares AB Full timeWe are hiring for Senior Interver Designers to join a team that develops advanced designs in Automotive domain. Educational Qualification: – Bachelor’s degree in Electrical Engineering, Power Electronics, or a related field. Job Summary: You will join a highly empowered agile team, as an Inverter Design Engineer and work in Automotive domain. Play...