Quality Assurance Specialist - Morrisville, NC, USA
- Expired: over a month ago. Applications are no longer accepted.
Circassia is a medical device company focused on point of care asthma diagnosis and management. Our market-leading NIOX® products are used in clinical settings by physicians around the world to improve asthma diagnosis and management and by leading research organisations conducting clinical studies on behalf of pharmaceutical companies. At present, Circassia provides products and services in around 50 countries. For more information please visit www.circassia.com.
In order to support these activities we are currently seeking a Quality Assurance Specialist
This role will report to the Quality Manager and will be a part of the Quality team, managing the day-to-day activities supporting the Supply Chain and Technical Operations team to deliver quality assurance oversight and day-to-day support. This role will require the individual to work closely with quality colleagues across Oxford and Uppsala to ensure that quality practices and processes across the sites are harmonised and consistent. This person will develop and improve processes for efficiency without compromising the regulatory requirements and quality framework for medical devices, in particular ISO13485 and FDA 21 CFR 80. As part of the role, this individual will engage with suppliers, partners and internal staff to assist in audits, investigations and critical supplier management.
Key Responsibilities of Role:
- Partner and work closely with cross-functional team members within Supply Chain, Technical Operations, Regulatory and Development to gain alignment on key quality processes
- Creates, adapts and inputs into Morrisville and corporate procedures, including policies, standard operating procedures and work instructions.
- Work in close partnership with the quality team to ensure that local Morrisville quality project deliverables are tracked and delivered against agreed timelines.
- Comfortable acting as host during external audits of Circassia processes.
- Work with cross-functional team members to support routine quality assurance activities, including in-coming goods inspections, warehouse operations and technical support.
- Actively engage in and monitor progress of non-conformances, corrective and preventative actions, complaints and change plans, in line with company procedures
- Participate in product vigilance activities in line with corporate and regulatory requirements.
- Work with other quality members, and cross-functional teams to support internal and external quality audits.
- Work in collaboration with other quality team members to support the regular device quality meetings, providing data and feedback on product metrics, including NC’s, CAPA’s, CP’s and investigations, as needed.
- Is an active participant in development projects, providing quality assurance guidance in line Circassia’s quality processes and aid document management in line with the company quality management system
- Work with cross-functional teams to identify training needs and deliver training as needed to support best practice and maintaining ongoing compliance
- Be a Circassia ambassador when representing the company internally and externally.
Qualifications and/or experience required to perform the role:
- Minimum of a Bachelor’s degree, in a Life Sciences related discipline
- Minimum of 5 years’ experience in a medical device field
- Proven track record in generating, analysing and summarising scientific data
- Proactively manage deliverables and respond appropriately with solutions to any potential issues and problems
- Preferably experienced in ISO13485 and MDSAP (Medical Device Single Audit Plan)
- Work with minimal direction and coordinate project timelines and deliverables
- Good communication and presentation skills
This position is based in Morrisville, NC, situated near the Research Triangle Park (RTP) and close to the RDU Airport. Our Morrisville office is a fully functioning division of the Circassia Group, PLC which is easily accessible from the surrounding areas. Our office also provides access to the great amenities in the Raleigh/Durham/Chapel Hill that the area has to offer and is a part of what has made it a Top 10 location to work in the US.
Circassia is proud to be an inclusive employer that supports our employees to realize and achieve their full potential. We are a diverse organization that champions a healthy work life balance.
As a truly global organization, international collaboration between colleagues in different countries is encouraged and supported. The Morrisville office works in a cohesive and collaborative manner, providing excellent opportunities for networking with colleagues.
We live and breathe our passion, recognition, integrity, drive, and effectiveness (PRIDE) values and ensure that we are working towards a common goal and this is to improve the quality of life of millions of people suffering from asthma. Each of these values help us to achieve excellent things, individually and together.
We value each individuals contribution and recognize the difference they make to the lives of asthma sufferers every day by supporting us in working towards our goal.
Thank you for considering a career at Circassia. If you would like to apply for the position, please apply online, ensuring you include the following information:
· Full name, location, email address and phone number
· Curriculum Vitae
· Cover letter
· Current salary
· Required salary
· Date available to start/notice period
After you have submitted this information, an email will be sent to you inviting you for a first interview. Due to the quantity of applications we receive, if you do not receive an email from us within 10 working days, please assume that you have been unsuccessful on this occasion.
Important notice to Employment businesses/ Agencies
Circassia does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Circassia’s human resources department to obtain prior written authorisation before referring any candidates to Circassia. The obtaining of prior written authorisation is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Circassia. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Circassia. Circassia shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
TechnologyView all jobs at Circassia