Top 18 Senior quality assurance engineer Jobs in Mansfield Ma

Senior Engineer, Quality Design Assurance
Integra LifeSciences —Mansfield, MA
- $81,650 - $112,700 a year
- Email
- 5 years
- Engineering
- Analysis skills
- Disability insurance
- Health insurance
Senior Quality Assurance Engineer (Defined Term)
Boston Scientific —Quincy, MA
- $89,200 - $169,500 a year
- Hybrid work
- 5 years
- Engineering
- Office
QA Analyst
Magellan Jets —Quincy, MA
- $85,000 - $115,000 a year
- Full-time
- 7 years
- Computer Science
- Office
- Paid holidays
- Health insurance
Quick Apply
Senior QA Engineer I
Flywire —Boston, MA
- $100,000 - $135,000 a year
- Full-time
- Hybrid work
- Computer Science
- Writing skills
- System design
- Employee stock purchase plan
Quick Apply
Senior Software QA Engineer
Nova Biomedical —Norwood, MA
- $120,000 - $130,000 a year
- Full-time
- Hybrid work
- Computer science
- Ability to lift 50 pounds
- Senior level
- Paid holidays
- Health insurance
Quick Apply
Senior Software Engineer - Investment Data Systems
Arrowstreet Capital —Boston, MA
- $95,000 - $165,000 a year
- Full-time
- Computer science
- Computer Science
- Senior level
Sr React Software Engineer
Branding Brand —Woonsocket, RI
- $100,000 - $110,000 a year
- Full-time
- Hybrid work
- Hospitality
- Computer Science
- Office
- Paid parental leave
- Work from home
Quick Apply
Full Stack Engineer
Fidelity TalentSource —Smithfield, RI
- $62.68 - $102.68 an hour
- Email
- Bachelor of Science
- Office
- AWS
Software Quality Assurance Senior Manager
Nova Biomedical —Waltham, MA
- $170,000 - $210,000 a year
- Full-time
- Ability to lift 50 pounds
- Analysis skills
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
Quick Apply
Senior Full Stack Engineer
Blue Cross Blue Shield of Massachusetts —Boston, MA
- $126,000 - $154,000 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Office
- Health insurance
- Dental insurance
Senior QA Engineer
Vestmark, Inc. —Boston, MA
- $107,000 - $125,000 a year
- Hybrid work
- Computer science
- Computer Science
- 5 years
Quick Apply
11d
Senior QA and Production Support Manager
Harvard University —Cambridge, MA
- Full-time
- Hybrid work
- Computer science
- Computer Science
- System design
- Commuter assistance
- Health insurance
AIT - AI Senior Developer Manager
PRICE WATERHOUSE COOPERS —Boston, MA
- $99,000 - $297,000 a year
- Bachelor's degree
- Quality control
- Mentoring
- Paid holidays
- Health insurance
12d
Lead Software Engineer II - Tax Product Development
BDO —Boston, MA
- $170,000 - $250,000 a year
- Full-time
- Computer Science
- Writing skills
- Finance
- Employee stock ownership plan
- Opportunities for advancement
12d
Data Quality Engineer
Kemper Insurance —Providence, RI
- $99,000 - $164,800 a year
- Full-time
- Remote
- Computer science
- 6 years
- Computer Science
- Health insurance
- Dental insurance
Quick Apply
10d
Senior Quality Assurance Engineer
TherapyNotes.com —United States
- $95,000 - $125,000 a year
- Full-time
- Remote
- Computer Science
- 5 years
- Bachelor of Science
- Profit sharing
- Disability insurance
Quick Apply
7d

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Senior Engineer, Quality Design Assurance

Integra LifeSciences -
Mansfield, MA

Apply Now

Job Details

Full-time
$81,650 - $112,700 a year

Benefits

Disability insurance
Health insurance
Dental insurance
401(k)
Vision insurance
Life insurance

Qualifications

Statistical software
Statistics
Team leadership
ISO standards
Quality control statistical data analysis
Six Sigma methodology implementation
GMP
Bachelor's degree in engineering
Quality risk management
Lean engineering
Project management experience in healthcare
Leading team collaboration initiatives
Biomedical regulatory compliance
Productivity software
Lean management
Manufacturing company experience
FDA regulations
Data analysis software

Full Job Description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Senior Engineer I, Quality Design Assurance, will work within the Integra Lifesciences CSS Quality organization to support the development of new Medical Devices. Working in the Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills. The position will support line extensions of existing products as part of the new product development process, as well as design related aspects of product and process transfers between manufacturing sites. This position will have responsibility for new product introduction and development to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities
or strategic inputs with moderately detailed instructions from Leaders and Stakeholders is a must-have.

For this Sr I role, ideal candidate will be a Subject Matter Expert with ISO11607, 10993, and functional cascading system requirements to component drawings, balancing the use of Y14.5 with the needs of the business.

RESPONSIBILITIES

Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners,

including software requirements and electrical/software architectures

Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management

and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).

Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and

processes.

Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques

Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical
Process Control.

Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations.
Support transfer to manufacturing activities both in product development and base business
Contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of

corrective actions.

Develop inspection methodology and acceptance criteria for inspection sampling plans
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk

Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.

Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation

test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines

Support Design and Technical Review

Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research &
Development, Regulatory, Marketing and Manufacturing

Demonstrate project management and leadership abilities
Participate to internal and external audits.
Maintain the Quality System

QUALIFICATIONS

Bachelor’s degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical)
5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
Strong analytical skills and a working knowledge of problem-solving methodologies
Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making

• Demonstrates excellent organizational, verbal and written communication skills • Proficient with the MS Office Suite, and statistical software.

Must be able to work independently with minimal supervision.
Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives

Salary Pay Range:

$81,650.00 - $112,700.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo

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Refine Your Search

senior quality assurance engineer jobs in mansfield ma

Senior Engineer, Quality Design Assurance

Senior Quality Assurance Engineer (Defined Term)

QA Analyst

Senior QA Engineer I

Senior Software QA Engineer

Senior Software Engineer - Investment Data Systems

Sr React Software Engineer

Full Stack Engineer

Software Quality Assurance Senior Manager

Senior Full Stack Engineer

Senior QA Engineer

Senior QA and Production Support Manager

AIT - AI Senior Developer Manager

Lead Software Engineer II - Tax Product Development

Data Quality Engineer

Senior Quality Assurance Engineer

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