Quality Manager at Boston Scientific Corporation Malaysia

Carlsbad, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Feb, 26

Salary

197000.0

Posted On

21 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Risk Analysis, Process Validation, Product Validation, Design Controls, Statistical Methods, cGMP, FMEAs, Hazard Analyses, Interpersonal Skills, Communication Skills, Leadership, Coaching, Mentoring, Continuous Improvement, Problem-Solving

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: ● Champion initiatives related to quality reporting systems and continuous improvement efforts. ● Identify opportunities for risk reduction and cost improvement while maintaining quality excellence. ● Provide leadership, coaching, mentoring, and development for Quality team members and cross-functional stakeholders. ● Serve as a site advocate for Quality Best Practices and current Good Manufacturing Practices (cGMP). ● Collaborate with engineering teams to develop and maintain Risk Management documentation, including FMEAs and hazard analyses. ● Build and scale the Quality Engineering function for disposable devices in alignment with BSCs growth strategy. ● Contribute to audits and regulatory inspections, providing expert guidance on quality systems. ● Set operational objectives, delegate assignments, and ensure timely completion of work by team members. ● Directly manage departmental activities, including performance, staffing, and budget. ● Ensure full compliance with quality system procedures and regulatory requirements. ● Foster a culture of collaboration, accountability, positivity, and continuous improvement. ● Demonstrate professionalism in all interactions with internal stakeholders and external partners. ● Bachelor's or Master's degree or equivalent combination of education and experience. ● Minimum of 15 years' experience in the medical device industry. ● Minimum of 5 years' experience in quality management. ● Experience working in Quality within catheter design and production or a similar medical device environment. ● Demonstrated experience with Design Controls, Risk Analysis, Process and Product Validation, and statistical methods. ● Applied understanding of 21 CFR 820, EN ISO 13485:2016, and ISO 14971:2019. ● Expertise in product sterilization, biocompatibility, and clean room compliance. ● Proven ability to lead through influence, manage sensitive situations, and interact effectively with executive stakeholders. ● Strong verbal and written communication skills with an ability to generate clear, concise, and timely reports. ● Ability to manage significant workloads, prioritize effectively, and deliver results under pressure. ● High attention to detail, accuracy, and proactive problem-solving skills. ● Strong interpersonal and listening skills, with the ability to adapt to change and build positive working relationships. ● Demonstrated success in creating realistic plans, setting goals, and executing cross-functional initiatives efficiently. Requisition ID: 618964 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

The Quality Manager will champion quality reporting systems and continuous improvement efforts while identifying opportunities for risk reduction and cost improvement. They will provide leadership and development for the Quality team and collaborate with engineering teams on Risk Management documentation.