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  • 10 - 13 Years
  • Posted : above 1 month

Job Description:

Associate Manager (Sustaining Engineering) Job

Location New Delhi, HR, IN

Company Boston Scientific

Location Pune (Maharashtra , India)
Hiring Manager Manoj Jain
Recruiter Nipun Anand

Department Quality

About the Role

The individual needs to be a self-motivated leader to develop and lead a Sustaining Engineering Quality function , Will lead the implementation and management of the Sustaining Quality requirements and Boston Scientifics global quality systems and Product Lifecycle Process (PLCP) The individual will also be responsible to lead a team of design quality assurance, quality system and quality specialist engineers to support all the sustaining engineering projects and ensure implementation of design assurance, quality system and global documentation requirements

The individual will also be responsible to develop SOPs and standardize the quality systems across all projects, divisions and lead the audits at the project level The individual needs to excel in people management with limited general supervision and strong technical background and project management skills to manage sustaining engineering projects for medical device

Your Responsibilities will include

Leads, coaches, and develops team members as necessary to support changing business needs
Leads the sustaining engineering quality projects and implements Quality systems, Boston Scientifics PLCP and align SOPs to meet local, regional and global internal and external guidelines and standards like ISO 13485, FDA 21CFR 820 etc
Collaborates with cross-functional teams on sustaining projects with a focus on Design for Manufacturability / Testability / Reliability
Leads corrective and preventive actions as required; proactively identifies and executes on opportunities for preventive actions
Provides Quality Engineering support for sustaining; addresses non-conformances through the NCEP system, driving PIR escalation and PIR processes when risk level warrants it
Supports the sustaining engineering team to provide support to all regional and global sustaining projects
Interfaces with assigned manufacturing, engineering, customer, vendor and subcontractor representatives to facilitate compliance, assists in determining responsibilities and solutions when required
Drives improvements in product quality based on out-of-box failure / complaint / in-process data analysis
Manages design quality changes to address complaints or product improvements
Works under the guidance sr quality management to develop and track sustaining quality indicators as per internal and external guidelines
Participates in internal and external audits; acts as Subject Matter Expert in sustaining quality engineering
Leads cost reduction projects, using Lean / Lean Business Process methodologies; contributes annually to the VIP savings program through Quality-driven projects as well as supporting projects driven by other functions
Supports implementation of functional excellence initiatives
Encourages problem-solving processes leading to leveragability of solutions across divisions
Leads Quality Planning activities related to Improvement projects, QMPs & other site projects as needed
Responsible for succession planning and the development and implementation of retention strategies
Assists in the development and monitoring of department budgets
Allocates/re-allocates internal and external resources, as needed with advice from Sr Quality Management
Ensures training plans and records for direct reports are compliant to Company-specific policies

What were looking for in you

Bachelors (or higher) degree in engineering with preference mechanical engineering, plastics and polymer engineering and biomedical engineering
10 years of experience in medical device Quality System with at least 5 years in leading sustaining quality function
3-4 years of hands on experience in sustaining quality supporting sustaining projects, design assurance and documentation

ASQ CMQ&OE/ Six Sigma Black Belt certification
Sound understanding of medical device regulatory requirements for Class II and III medical devices
Professional training & certification and working knowledge in Quality Management Systems including ISO 13485, FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations, Risk management ISO 14971, design assurance and control; Ability to understand other medical device regulations and standards
Proficient in project management tools resourcing, timelines, quality and budgets
Experienced in Process based work culture
Strong analytical and problem-solving skills
Experienced with major quality management systems (eg eCAPA, Windchill, Cockpit) desirable

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE BSX) is to transform lives through innovative medical solutions that improve the health of patients If youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen

Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Requisition ID 446586

Job Segment Assistant Manager, Medical, Engineer, Quality Manager, Chemical Engineer, Management, Healthcare, Engineering, Quality

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Others - other Industry
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 30th Jan 2020

Key Skills:

Company Profile:


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