Mid-level industry position
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Date: Apr 23, 2019
Company: Boston Scientific
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 Scientific’s 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 SOP’s 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.
- Leads, coaches, and develops team members as necessary to support changing business needs.
- Leads the sustaining engineering quality projects and implements Quality systems, Boston Scientific’s PLCP and align SOP’s 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:
- Bachelor’s (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 (e.g. eCAPA, Windchill, Cockpit) desirable
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 you’re looking to truly make a difference to people both around the world and around the corner, there’s 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
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