- Bachelor's degree in Science, Health, or Engineering
- Minimum of 3 years of related work experience in the medical device or pharmaceutical regulated industry
- Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485:2016, MDD, AIMD, AIMD, CMDR, RDC, JPAL, and MDSAP.
- Potential global and US travel up to 40%.
- Minimum of 2 years of experience working on acquisitions
- Project Management or Design Quality Assurance Experience
- High energy problem solver capable of driving items to closure.
- Experience within BSC quality systems.
- Strong presentation & communication skills.
- Computer skills required including Excel, Word, and PowerPoint.
- Experience working with across functions such as Operations, Regulatory, Research and Development, Clinical, and Quality.
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Quality Engineer III - Marlborough, United States - Boston Scientific
Description
Additional Location(s): US-MA-Marlborough; US-CA-Valencia; US-GA-Alpharetta; US-MN-Arden Hills; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
About the role: The Quality Engineer III will provide engineering support within the business development space focused on product development, remediation, and distribution of acquired products. The engineer will serve as a Global Quality representative leading awareness, visibility, and communication of quality initiatives to support global quality goals, priorities, and compliance in the new business development space. The engineer will act as a primary point of contact between an acquisition and the Global Quality Systems team.
Your responsibilities will include:
Develops integration strategies and approaches relating to Design Controls, Risk Management, and other areas of the Quality System as required.
Delivers and manages completion of functional deliverables, including updates to documents, procedures, and knowledge sharing documents as required.
Applies technical quality engineering principles and systematic problem-solving methodologies to acquisition products or sites.
Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management.
Maintains and enhances cross-functional team relationships within divisions, manufacturing plants, distribution centers, and global BSC network.
Advises management on potential improvements or enhancement to quality systems and processes in the company.
Assists in identifying and developing tools that facilitate BEST4 processes.
Required Qualifications:
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
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.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. 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
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. 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. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. 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.
