Specialist Medical Devices

3 months ago

Cramlington, United Kingdom Organon Full time

Organon is recruiting for the position of Specialist Medical Devices & Combination Products to join our world-class technical operations team. The team is responsible for managing the product lifecycle of Organon’s medical devices and combination products, a range of products that address the health needs of women around the globe and are critical to the success of Organon.

In this role, your responsibilities will include, but not limited to, leading design changes to these products and all technical aspects associated with these changes, the transfer of product designs to different manufacturing locations and participation, as a technical lead, in regulatory submission processes.

**Responsibilities**:

- Technical stewardship of assigned technical activities according to the requirements of Organon’s quality management system.
- Liaises with other technical leads in the development of objective evidence in support of design changes and/or regulatory submissions.
- Collaborate with teams internally and externally to aid the completion of technical projects according to business priorities.
- The communication of complex technical outcomes to internal stakeholders.
- Management of several competing technical projects according to the demands of the business.

**Requirements**:

- ** Degree level or similar qualification in an engineering/scientific discipline.**:

- Experience within the medical device and/or pharmaceutical industries, developing medical devices and/or the device constituent part of a combination product.
- Completed training in design control, risk management and other methodologies (e.g. six sigma) used within the medical device and pharmaceutical industries.
- Advanced technical authoring skills in the areas of design control and risk management to the latest regulations and standards.
- Demonstrable experience developing CAD models and drawings using Solidworks or a similar software package.
- Experience of project managing technical activities within a multi-functional team across different time zones.
- Comfortable challenging the status quo in a professional manner across the organisation to the benefit of the project and patient outcome.
- Preferrable although not essential to have experience of injection moulding and the qualification of moulded components.
- Preferrable although not essential to have experience participating in Notified Body and/or Competent Authority audits.
- Highly organised and methodical in completing technical assignments.

Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

**US and PR Residents Only**

For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

**Search Firm Representatives Please Read Carefully**

**Applicable to United States Positions Only**:Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

**Annualized S

  • Production Operator

    1 week ago

    Cramlington, Northumberland, United Kingdom Kelly Services Full time

    Job Summary:We are seeking a skilled Production Operator to join our team at a leading medical device manufacturing company. As a key member of our production team, you will be responsible for safely and efficiently producing high-quality single-use medical products in a cGMP-compliant cleanroom environment.Key Responsibilities:Safely Operate Equipment:...

  • Production Operative Day Shift 6am

    5 days ago

    Cramlington, Northumberland, United Kingdom Adecco Full time

    Job Summary: Adecco is currently recruiting Production Operatives for a prestigious client in the medical device industry. As a Production Operative, you will play a critical role in the production of life-saving medical products.Key Responsibilities:Safely and efficiently produce high-quality single-use medical products in a cGMP compliant cleanroom.Comply...

  • Production Operative Day Shift 6am

    1 week ago

    Cramlington, Northumberland, United Kingdom Adecco Full time

    Job Summary: Adecco is currently recruiting Production Operatives for a prestigious client in the medical device industry. As a Production Operative, you will play a critical role in the production of life-saving medical products.Key Responsibilities:Safely and efficiently produce high-quality single-use medical products in a cGMP compliant cleanroom.Comply...

  • Medical Product Manufacturing Technician

    1 week ago

    Cramlington, Northumberland, United Kingdom Kelly Services Full time

    Job SummaryWe are seeking a skilled Production Operator to join our team at Kelly Services, a leading provider of workforce solutions. As a Production Operator, you will play a critical role in the production of life-saving medical devices in a cleanroom environment.Key Responsibilities:Safely and efficiently assemble medical devices in a cGMP-compliant...

  • Cleanroom Production Specialist

    1 week ago

    Cramlington, Northumberland, United Kingdom Kelly Services Full time

    Job Summary:We are seeking a skilled Production Operator to join our team at a leading medical device manufacturing company. As a Production Operator, you will play a critical role in ensuring the safe and efficient production of high-quality medical products in a cGMP-compliant cleanroom environment.Key Responsibilities:Safely and efficiently produce...

  • Lead Medical Examiner Officer

    3 months ago

    Cramlington, United Kingdom Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust Full time

    Lead Medical Examiner Officer - Band 6 This role is to lead the medical examiner office which currently consists of 5 medical examiner officers and a number of part time Medical Examiners. The role is newly developed and the post holder will be expected to help drive forward the Medical Examiner office in terms of service development and...

  • Senior Specialist, Quality Management System

    3 months ago

    Cramlington, United Kingdom Organon Full time

    Support the management of Quality Management System (QMS), specifically: - Overseeing and coordinating the development, revision, review, approval, and posting of QMS documents to improve, enhance or deployment of new Topic material. - Own and manage an existing Topic that has been deployed - The QMS Sr. Specialist is also responsible for ensuring the...

  • Elderly Care Specialist

    16 minutes ago

    Cramlington, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    {"Job Title": "Elderly Care Specialist", "Job Summary": "We are seeking an experienced Elderly Care Specialist to join our team at Northumbria Healthcare NHS Foundation Trust. As an Elderly Care Specialist, you will work closely with our Elderly Care consultants to provide specialist and advanced clinical skills support to medical staff and the nursing team....

  • Advanced Clinical Specialist

    1 week ago

    Cramlington, Northumberland, United Kingdom NHS Jobs Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Elderly Care Practitioner to join our team at NHS Jobs. As a key member of our multidisciplinary team, you will play a vital role in delivering high-quality patient care and contributing to the development of our Elderly Care services.Key ResponsibilitiesDevelop and implement the Scope of...

  • Pipe Installation Specialist

    4 weeks ago

    Cramlington, Northumberland, United Kingdom Kinetic PLC Full time £17

    Position OverviewOur client is seeking a skilled Pipe Installation Specialist to become a vital part of their growing team. This role offers an opportunity for ongoing employment with an immediate start.CompensationCompetitive hourly rate.Work ScheduleDay shiftsMonday to FridayOptional Saturday shifts availableKey ResponsibilitiesThe successful candidate...

  • Procurement/sourcing Specialist Iii

    3 months ago

    Cramlington, United Kingdom Thermo Fisher Scientific Full time

    **About Thermo Fisher Scientific**: When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 130,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. You’ll find the resources here to achieve...

  • Frailty Practitioner

    6 days ago

    Cramlington, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    Job SummaryThe role of the Frailty Practitioner - Elderly Care Specialist is to provide high-quality patient care and support to our elderly population. This involves working at the interface with Elderly Care consultants, developing the scope of nursing practice, and providing nursing excellence in patient care.Main ResponsibilitiesProvide specialist and...

  • Frailty Practitioner

    2 weeks ago

    Cramlington, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    Job SummaryThe role of the Frailty Practitioner - Elderly Care Specialist is to provide high-quality patient care and support to our elderly population. This involves working at the interface with Elderly Care consultants, developing the scope of nursing practice, and providing nursing excellence in patient care.Main ResponsibilitiesProvide specialist and...

  • Specialist Transfusion Practitioner

    5 months ago

    Cramlington, United Kingdom Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust Full time

    An exciting opportunity has arisen for an ambitious and conscientious individual to join our Transfusion Practitioner Team. Applications are encouraged from enthusiastic, flexible and highly motivated individuals with a background in nursing or biomedical sciences. Excellent organisational and communication skills are required as well as an interest in...

  • Specialist Transfusion Practitioner

    5 months ago

    Cramlington, United Kingdom Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust Full time

    An exciting opportunity has arisen for an ambitious and conscientious individual to join our Transfusion Practitioner Team. Applications are encouraged from enthusiastic, flexible and highly motivated individuals with a background in nursing or biomedical sciences. Excellent organisational and communication skills are required as well as an interest in...

  • Quality Assurance Specialist

    4 days ago

    Cramlington, Northumberland, United Kingdom Sterling Pharma Solutions Full time

    Job SummarySterling Pharma Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a Senior Quality Assurance Officer, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesPerform quality assurance approvals of Process Record Sheets (PRS's), changes (process, analytical and...

  • Quality Assurance Specialist

    4 days ago

    Cramlington, Northumberland, United Kingdom Sterling Pharma Solutions Full time

    Job SummarySterling Pharma Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a Senior Quality Assurance Officer, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesPerform quality assurance approvals of Process Record Sheets (PRS's), changes (process, analytical and...

  • Frailty Practitioner

    6 days ago

    Cramlington, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    About the RoleWe are seeking an experienced and skilled nurse practitioner to join our team at Northumbria Healthcare NHS Foundation Trust. As a Frailty Practitioner, you will play a vital role in providing high-quality care to our elderly patients, working closely with our multidisciplinary team to deliver exceptional patient outcomes.Key...

  • Frailty Practitioner

    1 week ago

    Cramlington, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    About the RoleWe are seeking an experienced and skilled nurse practitioner to join our team at Northumbria Healthcare NHS Foundation Trust. As a Frailty Practitioner, you will play a vital role in providing high-quality care to our elderly patients, working closely with our multidisciplinary team to deliver exceptional patient outcomes.Key...

  • Frailty Practitioner

    2 days ago

    Cramlington, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    About the RoleWe are seeking an experienced and skilled nurse practitioner to join our team at Northumbria Healthcare NHS Foundation Trust. As a Frailty Practitioner, you will play a vital role in providing high-quality care to our elderly patients, working closely with our multidisciplinary team to deliver exceptional patient outcomes.Key...