- Lead the manufacturing Quality group of Quality engineers and Quality Control technicians.
- Quality System owner of Nonconformances (NCR), Corrective and Preventive Action (CAPA), Customer Complaints, and Change Control among other systems.
- Responsible for Medical Device Reporting (MDR) to the FDA.
- Responsible for the environmental monitoring program at AVI.
- Oversee the equipment control and calibration programs.
- Manage incoming inspection.
- Identify and lead continuous improvement activities to enhance AVIs Quality Systems and manufacturing processes.
- Support the internal audit program.
- Willing to be a hands-on contributor within the manufacturing Quality team.
- BS in related technical field, preferably Engineering
- 10+ years of Quality experience in the Life Science or Medical Device Industries
- Minimum of 2 years in a Managerial role.
- Embody the Access Vascular Guiding Principles
- Working knowledge of 21 CFR 820 and ISO 13485
- Ability to review and write technical documentation
- Self-initiator with strong organization skills
- Teamwork, flexibility and adaptability to change
- Ability to communicate and lead through influence
-
Quality Manager
2 weeks ago
Amtech Billerica, United States**Organization Summary** · Founded in 1981, Amtech Systems is a trusted global supplier of essential semiconductor equipment and consumables serving various industries within the power semiconductor market, including mobile, computing, industrial, automotive, telecom, medical, an ...
-
Quality Assurance Manager
3 weeks ago
Wimmer Solutions Billerica, United StatesSENIOR ASSOCIATE, COMPLIANCE (PRODUCT QUALITY) · BILLERICA, MA (ONSITE) · At Wimmer Solutions, we believe care creates community. We work smart; we have built a reputation for results-oriented, innovative, business and technology solutions that help companies execute on their str ...
-
PAREXEL Billerica, United States RemoteHome Based, US · As a Sr Quality Manager in Technology Quality Management (TQM) you will manage efforts to define, adopt and oversee compliance to processes and standards as the fundamental baseline for technology solution development, validation and delivery. You will support e ...
-
Quality Manager
6 days ago
Boyd Woburn, United States**Job Title**: Quality Manager · **Company Overview**: Boyd Woburn is a leading aerospace components manufacturing company dedicated to delivering high-quality products that meet or exceed industry standards. With a commitment to precision engineering and innovation, we strive to ...
-
Functional Quality Assurance Manager
2 weeks ago
Lockheed Martin Chelmsford, United States**Job ID**: 661173BR · **Date posted**: Feb. 15, 2024 · **Program**: Functional · **Description**:Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members ...
-
Quality Control Manager
3 weeks ago
Meridian Adhesives Group Billerica, United StatesCOMPANY OVERVIEW · Meridian Adhesives Group is a rapidly growing full service global adhesive solutions provider, specializing in adhesive technologies used in electronics, industrial, and infrastructure applications. Fueled by a series of strategic acquisitions since its formati ...
-
Quality Manager
2 days ago
ProAmpac Walden, United States**Company Overview** · ProAmpac is a leading global flexible packaging company with comprehensive product offerings. We provide creative packaging solutions, industry-leading customer service and award-winning innovation to a diverse global marketplace. We are guided in our work ...
-
Quality Assurance Manager
2 weeks ago
EPM Scientific Billerica, United StatesTitle: Quality Assurance Manager (Medical Device) · Location: Billerica, MA · A pharma/med device company is seeking a Quality Manager to spearhead Quality activities related to their combination products. The Quality Manager will be responsible for all aspects of QA for medical ...
-
Sr. Manager, Quality
2 weeks ago
EPM Scientific Billerica, United StatesSr. Manager, Quality (Medical Device) (PR/ · Billerica, Massachusetts · Apply with Indeed · Title: Manager/Sr. Manager, Quality (Medial Device) · A leading pharma/med device company is seeking a Manager/Sr. Manager to spearhead Quality activities related to their combination pr ...
-
Quality Assurance Manager
3 weeks ago
EPM Scientific Billerica, United StatesTitle: Quality Assurance Manager (Medical Device) · Location: Billerica, MA · All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description. · A pharma/med device company is seeking a Quality Manager to spe ...
-
Quality Manager
2 weeks ago
Intertek Boxborough, United States**Quality Manager** · Intertek, a Nationally Recognized Testing Lab (NRTL) and leading provider of ATIC (Assurance, Testing, Inspection, and Certification) Services, is looking for a **Quality Manager **to join our Electrical team in **Boxborough, MA **. This is a fantastic oppor ...
-
Quality Manager
3 weeks ago
Finish Line Staffing Bedford, United StatesBachelors degree in manufacturing, Industrial, Electrical, or Mechanical Engineering · 3+ years in a leadership position. · 5+ years of hand-on professional experience in a Medical Device manufacturing environment · Experience in a regulated environment such as medical devices ...
-
Quality Manager
2 weeks ago
Microwave Components and Systems, Inc. Westborough, United States**Benefits**: · - 401(k) · - 401(k) matching · - Dental insurance · - Health insurance · - Paid time off · Schedule: · - Monday to Friday · Work Location: In person ...
-
Quality Manager
3 weeks ago
vascular access inc Billerica, United StatesJob Description · * No recruiters please · The Quality Manager is responsible for leading the manufacturing Quality group at AVI. This is a collaborative position working closely with Operations to support production management and production initiatives while ensuring compliance ...
-
Quality Manager
3 weeks ago
Access Vascular Inc Billerica, United StatesJob Description *No recruiters pleaseThe Quality Manager is responsible for leading the manufacturing Quality group at AVI. This is a collaborative position working closely with Operations to support production management and production initiatives while ensuring compliance with ...
-
Omega Dynamics Newton, United StatesA good job can make a big difference. With us, it can even give second chances at life. · As an international non-profit organization, our goal is to give as many blood cancer patients as possible a second chance at life and provide access to stem cell transplants. To help even m ...
-
Senior Manager, Quality Assurance
3 weeks ago
Sun Pharma Billerica, United StatesJob Summary · for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. · compliance of establish Quality Management System (QMS ...
-
Quality Assurance Compliance Manager
3 weeks ago
Oxenham Group Billerica, United StatesThis range is provided by Oxenham Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $160,000.00/yr - $175,000.00/yr · Direct message the job poster from Oxenham Group · Medical Device Quality & Regulat ...
-
Sr. Manager Quality Systems
2 weeks ago
Oxenham Group Billerica, United States4 weeks ago · Be among the first 25 applicants · This range is provided by Oxenham Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $160,000.00/yr - $175,000.00/yr · Direct message the job poster fro ...
-
Quality Manager
3 weeks ago
Titan Industries East Side, United StatesAs one of the most successful and innovative personnel service companies in Germany, we are currently seeking a Quality Manager (m/f/d) in full-time for our renowned client in Haldensleben on the East Side. Your responsibilities will include: - Planning and coordinating the audit ...
Quality Manager - Billerica, United States - Access Vascular Inc
Description
Job Description*No recruiters please
The Quality Manager is responsible for leading the manufacturing Quality group at AVI. This is a collaborative position working closely with Operations to support production management and production initiatives while ensuring compliance with AVIs Quality Management System (QMS) and FDA Quality System Regulation (QSR) requirements. This position is located in Billerica, MA, no relocation offered.
Duties & Responsibilities
The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .