Job details
Job type full-time
Full job description
Quality specialist – global service and support (gss)
How will you make an impact?
Reporting to the srManager of quality for genetic science division supporting global service and support (gss) this role is responsible for managing quality complaint escalations, owning capa’s, and leading a cross functional team to drive issues to resolutionThe quality specialist will liaise with gss partners ensuring investigations are in compliance with iso 13485, participate in developing quality standards to meet both regional and international requirements.
What will you do?
Partner with gss, r&d, product management and site manufacturing on gss quality investigations.
May support internal audits ensuring compliance to applicable international and national standards, regulations, and guidelines.
Create, track and present gss quality escalation updates/status, milestones, issues, actions, and report outs to stakeholders, site, divisional and group leadership.
Drive gss quality escalations and capa’s to resolution and completion
Work with a customer centric mindset to ensure gss quality escalations and capa’s are aligned with customer expectations (internal & external) and delivered accordingly.
Work collaboratively and build effective relationships with critical stakeholders, contractors, etcTo enable timely resolutions to gss quality investigations and capa’s
How will you get here?
3-5 years managing quality investigations and capa’s
Excellent understanding of regulations and standards such as 21 cfr 820, iso 13485, iso 9001, or similar standards/regulations in support of a service organization.
Demonstrates a sense of urgency, contagious optimism and a “can do” attitude.
Results driven with a strong capability to influence without authority
Demonstrated skills in project management
Must have a good knowledge of the inner workings of a large company.
Good technical writing skills, excellent time management skills and ability to work independently required.
Solutions oriented with a forward focused mentality; see problems coming and develop strategic solutions, with creativity in problem solving
Proven ability to effectively develop, communicate, and gain support cross functionally and with a wide range of stakeholders.
Excellent judgment and creative problem-solving skills, excellent interpersonal skills, organizational skills, written and oral communication skills
Required experience
Bachelor`s degree is required (biological sciences or related degree); advanced degree is a plus
3-5 years of experience investigating complaints and capa’s in an fda regulated industry (drugs, biologics, medical devices, or related industry)
Working conditions:
Remote position located in north america with 0-25% domestic and international travel.
