Quality Systems Manager Bedford, MA
: Job Details :

Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves surgical outcomes for their patients in a thriving $6B+ Surgical Stapler market.

Rooted in a talent dense culture, we are committed to innovation, foster continuous growth and achieve great heights, together. At Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.

As the Quality Systems Manager at Lexington Medical, you will lead the administration, maintenance, and continuous improvement of our Quality Management System (QMS), ensuring alignment with all applicable quality and regulatory requirements.

Our ideal candidate thrives in a fast-paced, entrepreneurial environment, takes initiative, and brings a hands-on, results-driven approach to quality leadership. You should be a collaborative team player who excels at managing and enhancing QMS processes while ensuring ongoing compliance. If you're passionate about quality, enjoy wearing multiple hats, and want to make an immediate impact at a rapidly growing medical device company, this role could be the perfect fit for you.

Responsibilities:

• Lead the development, implementation, and upkeep of the Electronic Quality Management System (eQMS), ensuring compliance with ISO 13485, FDA 21 CFR Part 820 (QMSR), MDSAP, and other applicable regulations.
• Identify opportunities and lead initiatives to improve QMS workflows, including change control, training, CAPA, nonconformance, audits, design control, risk management, production/process controls, and supplier management.
• Manage the full lifecycle of the QMS to support continuous compliance and system effectiveness.
• Create and execute data analysis plans to track and trend key performance indicators (KPIs) and support data-driven decision making.
• Maintain and manage standard operating procedures (SOPs) and related documentation to meet global regulatory requirements.
• Collaborate with cross-functional teams—operations, quality, engineering, regulatory, and manufacturing—to ensure consistent product quality.
• Conduct or support eQMS system validation activities, as needed.
• Support audit readiness and participate in internal and external audits.
• Perform other QMS-related duties as assigned.

Qualifications:

• Bachelor's degree in a technical field; quality-related certifications (e.g., CQA, CQE) are a plus.
• 3+ years of hands-on experience implementing and maintaining an electronic Quality Management System (eQMS) in the medical device industry; experience with Arena is strongly preferred.
• Proven ability to develop and manage QMS reporting metrics that support data-driven decisions across the organization.
• Strong team player with experience leading QMS activities in a cross-functional setting.
• Ability to apply risk-based thinking to quality processes and decision-making.
• Experience preparing for and supporting external regulatory audits (e.g., ISO 13485, ISO 9001, MDSAP, FDA).
• In-depth knowledge of international quality regulations and standards, with practical experience in ISO 13485, MDSAP, and/or FDA 21 CFR Part 820.
• Strong communication and interpersonal skills with the ability to influence, collaborate, and drive quality initiatives across departments.
• Skilled in applying structured problem-solving methodologies with a practical, results-oriented mindset.

Create a Job Alert

Interested in building your career at Lexington Medical? Get future opportunities sent straight to your email.

Apply for this job

*

First Name *

Last Name *

Preferred First Name

Email *

Phone

Resume/CV

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

LinkedIn Profile

Are you authorized to work in the US? * Select...

At any time, now or in the future, will you require visa sponsorship to work in the US? * Select...

We ask all applicants and offer visa sponsorship for a variety of positions.

Are you available to work onsite in Bedford, MA office? * Select...

Have you used Arena as an eQMS platform? * Select...

Do you have 3 or more years of hands-on experience implementing and maintaining an electronic Quality Management System (eQMS) in the medical device industry? * Select...

Do you have experience preparing for and supporting external regulatory audits (e.g., ISO 13485, ISO 9001, MDSAP, FDA)? * Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Lexington Medical's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A disabled veteran is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A recently separated veteran means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An active duty wartime or campaign badge veteran means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An Armed forces service medal veteran means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Voluntary Self-Identification of DisabilityForm CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

• Alcohol or other substance use disorder (not currently using drugs illegally)
• Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heart disease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficulty hearing
• Diabetes
• Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
• Epilepsy or other seizure disorder
• Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
• Intellectual or developmental disability
• Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
• Nervous system condition, for example, migraine headaches, Parkinson's disease, multiple sclerosis (MS)
• Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
• Partial or complete paralysis (any cause)
• Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
• Short stature (dwarfism)
• Traumatic brain injury

Disability Status Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

#J-18808-Ljbffr