Quality Manager at Boston Scientific Corporation Malaysia

Coventry, Rhode Island, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

197000.0

Posted On

02 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Systems, Manufacturing, FDA Regulations, ISO 13485, ISO 11135, CAPA Systems, Validation, Risk Management, Process Controls, Leadership, Coaching, Collaboration, Sterility Assurance, Sterilization Validation, Microbiology

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Support sterilization operations by consulting on quality and sterilization issues, problem-solving, and driving proactive risk mitigation strategies. Design, implement, and improve inspection, testing, and validation processes to ensure compliance and process control. Facilitate global product sterility release through ongoing quality assurance activities and direct collaboration with Global Sterility Assurance. Ensure site compliance with applicable FDA, ISO 13485, ISO 11135, and other relevant global regulations and standards. Support the development and evolution of the Quality function's long-term goals, structure, and performance metrics. Minimum of 7 years' experience in Quality Assurance, Quality Systems, or Manufacturing in the medical device, pharmaceutical, or other regulated industry Minimum of 3 years' experience managing or leading technical or quality teams Strong knowledge of FDA regulations, ISO 13485, and ISO 11135 Demonstrated experience with CAPA systems, validation, risk management, and process controls Proven leadership and coaching capabilities across technical and non-technical staff Experience collaborating across departments and global teams to achieve business objectives Bachelor's or advanced degree in Engineering, Life Sciences, or a related technical field Experience with sterility assurance, sterilization validation, or microbiology-based quality systems Lean, Six Sigma, or other continuous improvement certifications Familiarity with product release and reverse logistics (returns, clinical, recall, stock management) in a regulated industry Requisition ID: 617585 Minimum Salary: $ 103700 Maximum Salary: $ 197000 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

Support sterilization operations by consulting on quality and sterilization issues, problem-solving, and driving proactive risk mitigation strategies. Ensure site compliance with applicable FDA, ISO 13485, ISO 11135, and other relevant global regulations and standards.