- Title: Jr. Quality Engineer
- Code: RCI-5570
- Location: Santa Clara California (CA) 95054
- Posted Date: 10/05/2020
- Duration: 12 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Important Updates from the manager
Will be working remote as of now however they will come to office once the situation is better
- Medical device or pharma background is needed
- Experience with CAPA or root cause analysis is a plus
- will be interacting to a lot of people in middle east & Asia pacific
- Would be establishing process and procedures
- Technical background is a plus
- Quality system oriented person
- Master’s degree will work
- Manager can train people on regulatory affairs
- Must have a Engineering or science background
- Looking for entry level person
- Motivated, excellent work ethics & excellent communication skills needed
- Will be leading a lot of deliverables for small projects
- Providing compliance support to regulatory stake holders
- Excel experience is needed
- Lead a lot of CAPA investigations
- Would be providing quality systems and operations support to regulatory team
Manager is not looking for a person with regulatory affairs experience; but rather technical/ engineering/ quality systems exposure.
Regulatory Affairs Operations Department:
- This support includes, but is not limited to, establishing processes and procedures for the Product Approval Key Process to ensure conformance to regulatory requirements, innovative solutions to enable release of approved product to the market, CAPA investigations and definition of resolution plans to prevent recurrence/occurrence, keeping a pulse on global Emerging Issues and assessing impact to the Quality System or registrations, regulatory document management (issuance, archival, etc.), and Audit Support (external, internal, corporate).
- The Regulatory Affairs Operations (Reg Ops) organization is a divisional function responsible for providing Quality System and Compliance support to the Regulatory Affairs key stakeholders, and to the Vascular Business Unit.
- Business impact and benefit to are exhibited by ensuring regulatory and addendum labeling requirements are robust in the quality system; by increasing our compliance portfolio; by supporting Quality Systems roll out to the RA organization; and by strengthening conformance to regulatory requirements.
Manager is looking for
- Looking for a motivated individual with excellent work ethic and communication skills, with technical background, that can lead projects and coordinate project/submission deliverables with multiple stakeholders, cross-functional teams, and individuals located across the world (WW).
- The role is titled “Pan-Franchise Regulatory Operations Specialist” – and I’d like to state upfront I am not looking for a person with regulatory affairs experience; but rather technical/ engineering/ quality systems exposure.
- My entire team is comprised of folks with either engineering or science backgrounds (I myself am a Mechanical Engineer by training), and that’s one of the biggest values we bring to the partnership with Regulatory Affairs.