Director of Quality Remedi SeniorCare
THIS JOB HAS EXPIRED Reports to: RTG President/COO
Department: Remedi Technology Group
Classification:Full time Exempt
Develop and implement RTG quality systems inclusive of process and quality documentation, change control, and Quality Management Reviews. Assure compliance with internal quality standards. While not governed by the FDA, Remedi Technology Group shall validate all system components per FDA guidances and shall comply with cGMPs. Leads RTG?s Quality organization to identify, develop and implement ?best quality practices?. Works with RTG leadership to establish quality and performance objectives, budgets and forecasts and manages the activities to ensure they are met.
Responsibilities will include continuous review of quality systems/ processes, and compliance with internal quality standards:
Develop a robust, ?best-in-class? Quality System to ensure early identification & resolution of potential risks, compliance gaps and opportunities for improvement, through challenging & effective internal/ external audits, adopting ?best practices?, applying advanced quality/IQP methods & tools, and utilizing effective & efficient quality assurance technologies, always with Customer Driven Quality philosophies.
As a member of the Leadership Team, provides direction and support to establish the Quality goals & objectives for RTG and the key performance & quality indices. Chairs Quality Management Reviews driving superior product quality & consistency, improved process capability & reliability, and a continuous improvement culture. Coordinate the establishment of the Paxit help desk.
Executes and documents non-conformance reports, investigations, CAPA, i.e. resolution of quality issues, and in complying with specifications, SOPs, and State Board of Pharmacy requirements.
Chairs the RTG Change Review Board (change control) and provides technical & regulatory guidance/input regarding the change control process; reviews preliminary proposals & final change requests including supporting documentation to determine adequacy, effectiveness & impact on product safety, efficacy, consistency, claims, customer & regulatory requirements.
Provides input and assures new products, product & process improvements are successfully developed and implemented with adequate process capability & control systems, a robust quality plan with supporting documentation, and proper qualifications & validation to assure high & sustainable quality products.
Develops the Quality group with the technical knowledge, competence, experience, execution excellence and interpersonal & influencing skills to be recognized as reliable authorities & leaders. Ensures adequate, competent quality resources and support are available for executing required work schedules as well as major company/site priorities & projects assuring risk reduction & continuous quality improvement of our products, processes & systems.
Authors hardware and software validation protocols.
Builds quality organization.
Bachelor?s degree, Master?s degree in Sciences or Engineering preferred.
Certified Six Sigma Green / Black Belt preferred.
10 years of experience in Medical Device, Pharmaceutical and/or
High Technology Industry, with increasing responsibility
3 years in auditing/regulatory compliance
3 years as Manager in R&D, Operations or Engineering
3 years as Manager in non-Quality function
9 years in Quality Assurance/Control
6 years in Quality Management including 3 years as Site Quality Head/Director
Direct FDA interactions, e.g. inspection leader
Major start-up (facility, mfg. line, new product)
Must be able to communicate effectively both verbally and written with English as the primary language,
including cross-cultural collaboration. Must have exceptional leadership and interpersonal skills with the
ability to motivate and lead, strong problem solving abilities, and a strong customer service focus.
Must be dependable with ability to be flexible, function independently and works under pressure with
multiple tasks and deadlines. Must have strong organizational, time management skills, risk
Medical device/pharmaceutical GMP & ISO Standards proficiency
Compliance/requirements auditing & application of quality systems
Yes - Quality team.
Contact with Others:
High frequency of contact with employees, customers, and vendors requires effective interpersonal skills
exhibiting a pleasant out-going and caring attitude, the ability to interact positively with a professional
attitude and demeanor.
This position will be exposed to highly confidential information and data that disclosed would be against
Federal and State HIPPA law and contrary to the company?s policies and to professional ethics.
Mental/ Visual Demands:
Flow of work requires normal mental and visual demands.
up to 50%
||Baltimore, MD |
THIS JOB HAS EXPIRED