Sr Quality Engineer -Software Auditor
Additional Location(s):
US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove Diversity - 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:
Due to the increasing complexity of clinical trials and regulatory obligations, the components of a Clinical Quality audit program are constantly evolving, especially in the software validation and cybersecurity related areas.
This Sr.
Quality Systems Engineer global role will work directly with the Clinical Quality Auditor lead and serve as the software quality representative that performs, supports, and maintains clinical vendor software assessments for all of Boston Scientific's external clinical vendors.
The software assessments will review the vendor's compliance to various regulations, their software development lifecycle (SDLC) and related software validation procedures.
This position is hybrid and can be based out of Marlborough, MA, Arden Hills, MN, or Maple Grove, MN.
Your responsibilities will include:
Play a key role in vendor management by identifying the software quality system needs from a vendor and ensures that vendors are qualified in a manner including performing SDLC Assessments for software vendors including clinical.
Partner with the audit team and support decision making if a software assessment is needed for clinical and medical device vendors.
Perform Quality Software Vendor assessment audits to review compliance to FDA Part 820, IEC 62304, ISO 13485, ISO 14971, MDR, and MDSAP requirements.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
Develop and contribute to audit reports including scope, audit details, clearly communicate findings with identified risk severity, likelihood, impact, and risk remediation recommendations.
Following up on activities to address outcome of conducted audits until their resolution.
To own the software auditing processes, which are always evolving.
To fulfill all duties and responsibilities in line with the established timelines.
Providing support in definition of requirements for quality improvement initiatives Active participation in quality improvement projects as defined by management/leadership Required
Qualifications:
Bachelor's level degree in Science/Engineering/Computer Science/Software Engineering or related discipline 2
years of related experience, including experience supporting Quality Systems for Software or related discipline 5
years of technical experience in the medical device or pharmaceutical industry 2
years of experience with external auditing and corrective and preventive action (CAPA) Working knowledge of regional and international quality system requirements including 21 CFR 820 (including Part 11), ISO 13485, EU MDR and cGxP for Medical Devices Must have good understanding of quality system requirements and how each quality system element connects.
Experience managing projects and project deliverables to completion Knowledge of Software Development Life Cycle (SDLC) Preferred
Qualifications:
Clinical experience or knowledge of clinical evaluations beneficial Knowledge of Clinical Trials regulations (both US and rest of the world) including ISO 14155 and 21 CFR 812 Basic Understanding of HIPAA/GDPR and data security regulations beneficial Experience/Understanding of risk management as per ISO 14971 Experience with CAPA, Vendor Controls, Vender Audits, Complaint Handling and External Audits Skilled at testing process and methodologies ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) Excellent organizational, communication and collaboration skills Strong critical thinking and analytical skills:
process and results-oriented Comfortable speaking and presenting to leadership Ability to travel up to 10% (domestic or international) #LI-Hybrid Requisition ID:
561707 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 drug-free workplace.
Pursuant to Va.
Code 2.
2-4312 (2000), 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.
RSRBSC EMV2 Recommended Skills Analytical Assessments Auditing Certified Quality Engineer Clinical Trials Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove Diversity - 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:
Due to the increasing complexity of clinical trials and regulatory obligations, the components of a Clinical Quality audit program are constantly evolving, especially in the software validation and cybersecurity related areas.
This Sr.
Quality Systems Engineer global role will work directly with the Clinical Quality Auditor lead and serve as the software quality representative that performs, supports, and maintains clinical vendor software assessments for all of Boston Scientific's external clinical vendors.
The software assessments will review the vendor's compliance to various regulations, their software development lifecycle (SDLC) and related software validation procedures.
This position is hybrid and can be based out of Marlborough, MA, Arden Hills, MN, or Maple Grove, MN.
Your responsibilities will include:
Play a key role in vendor management by identifying the software quality system needs from a vendor and ensures that vendors are qualified in a manner including performing SDLC Assessments for software vendors including clinical.
Partner with the audit team and support decision making if a software assessment is needed for clinical and medical device vendors.
Perform Quality Software Vendor assessment audits to review compliance to FDA Part 820, IEC 62304, ISO 13485, ISO 14971, MDR, and MDSAP requirements.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
Develop and contribute to audit reports including scope, audit details, clearly communicate findings with identified risk severity, likelihood, impact, and risk remediation recommendations.
Following up on activities to address outcome of conducted audits until their resolution.
To own the software auditing processes, which are always evolving.
To fulfill all duties and responsibilities in line with the established timelines.
Providing support in definition of requirements for quality improvement initiatives Active participation in quality improvement projects as defined by management/leadership Required
Qualifications:
Bachelor's level degree in Science/Engineering/Computer Science/Software Engineering or related discipline 2
years of related experience, including experience supporting Quality Systems for Software or related discipline 5
years of technical experience in the medical device or pharmaceutical industry 2
years of experience with external auditing and corrective and preventive action (CAPA) Working knowledge of regional and international quality system requirements including 21 CFR 820 (including Part 11), ISO 13485, EU MDR and cGxP for Medical Devices Must have good understanding of quality system requirements and how each quality system element connects.
Experience managing projects and project deliverables to completion Knowledge of Software Development Life Cycle (SDLC) Preferred
Qualifications:
Clinical experience or knowledge of clinical evaluations beneficial Knowledge of Clinical Trials regulations (both US and rest of the world) including ISO 14155 and 21 CFR 812 Basic Understanding of HIPAA/GDPR and data security regulations beneficial Experience/Understanding of risk management as per ISO 14971 Experience with CAPA, Vendor Controls, Vender Audits, Complaint Handling and External Audits Skilled at testing process and methodologies ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) Excellent organizational, communication and collaboration skills Strong critical thinking and analytical skills:
process and results-oriented Comfortable speaking and presenting to leadership Ability to travel up to 10% (domestic or international) #LI-Hybrid Requisition ID:
561707 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 drug-free workplace.
Pursuant to Va.
Code 2.
2-4312 (2000), 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.
RSRBSC EMV2 Recommended Skills Analytical Assessments Auditing Certified Quality Engineer Clinical Trials Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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