We are looking for only those candidates who can attain the Interview Drive.

(Immediate Joiners or Max 15 days Notice period)

Senior Design Quality Assuarance

About Company :

It is the Recruitment Process Outsourcing (RPO) division of ABC Consultants.

Location : Gurgaon

Experience : 8 - 12 Years

Function : R&D/Research & Development

Vacancy : 1

Job Description :

About the role :

- The R&D Design Quality Assurance Engineer will be a part of the R&D Quality organization and deployed on R&D project teams to lead the quality engineering function on individual projects.

- The individual will be responsible for assuring all requirements for the Product Development Process (PDP), Risk Management, Design Controls, Verification and Validation Testing, and External Manufacturer Production Controls are met by :

a.) Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design Verification & Validation (V&V), Usability Testing, Software Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured,

b.) Leading the execution of quality deliverables such as Risk Management Plan/Report, Hazard Analyses, Use and Design FMEA, Usability Testing, Quality Plans, and Field Assessment Plans,

c.) Providing quality and compliance input and coaching for product development, and

d.) Supporting Corporate Quality initiatives utilizing their PDP, Risk Management, and Design Controls expertise.

- The individual will be responsible for all Design assurance related SOP's and documentation for the assigned projects and will provide inputs to the Quality Systems team to monitor and track all quality indicators.

- The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures and should be comfortable working in a matrix organizational structure.

Your Responsibilities will include :

- Be a part of core project team and lead the quality engineering across the entire development cycle.

- Lead the development and implementation of design verification and validation plans with project design lead.

- Lead product usability and design validation efforts for new product development and design change projects.

- Co-lead the development of CTQ- s, design input and output documents.

- Lead reliability testing plans and provide statistical testing & reliability plans - internal and local vendors

- Responsible for co-leading stage gate reviews and signatory on all PDP document approvals

- Transition projects from Exploratory and Technology development (TDP) phase to product development phase (PDP) and receive ownership of all quality documentation.

- Participate and implement tools like Design of Experiments (DOE- s), xFMEA sessions, Risk Management and ensure compliance to CTQ's and safety requirements.

- Manage electronic document control and version control on all project related documents.

- Ensure adherence to the quality systems and design assurance SOPs and Boston Scientific's PLCP.

- Partner with process development engineers to design transfer to manufacturing.

- Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables.

- Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.

- Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).

- Lead CAPA efforts, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why's analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).

- Lead the internal and external audits as an auditee for the PDP project activities.

What we're looking for in you :

- Bachelors (or higher) degree in engineering with preference mechanical engineering, electronics and embedded systems, plastics and polymer engineering and biomedical engineering.

- 5+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation.

- Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.

- Sound understanding of medical device regulatory requirements for Class II and III medical devices.

- Project planning - resourcing, timelines, quality and budgets.

- Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).

- Past experience as a design engineer will be an added advantage.

- Preference for candidates with PMP certification or similar project management training and experience

- Proficient in project management tools like MS project.

- Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.

- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

- For those individuals that supervise others, the following statements are applicable:

- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

- Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Qualification : Btech - Mechanical

Working Days : 5 Days a Week ( to )

Job Nature : Full Time

Interested candidates can Revert us back with their updated CV on mail or Whatsaap

Only 1 Vacancies Left For This Position

For Further Details or queries you can call on below given recruiters numbers

Sunny Sharma
HR Managing Director
Western Service Providers

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