- Bachelor's Degree in a relevant scientific, or engineering discipline with 10+ years of demonstrated QA experience in a medical device firm.
- ASQ certification (CQE, CQA, or CMQ/OE) is highly preferred.
- Demonstrated ability to facilitate regulatory audits and inquiries.
- Strong working knowledge and understanding of FDA regulations, ISO standards, quality principles, concepts, industry practices, and standards.
- Demonstrated ability to develop, communicate and influence solutions to complex problems.
- Applies knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.
- Exercises judgment within well-defined and established procedures and practices to determine appropriate actions.
- Shows strong initiative and independence. Able to perform routine work and fulfill responsibilities with little or no additional instruction.
- Detail-oriented with good organization and time management skills.
- Strong interpersonal and verbal/written communication skills required.
- Ability to effectively participate and contribute on multi-disciplinary teams.
-
Quality Assurance Manager
3 weeks ago
SN&N Electronics Morgan Hill, United StatesCompany Description · SN&N Electronics, Inc. is a product development firm located in Morgan Hill, CA. We partner with technology startups, Fortune 500 companies, and academic institutions to bring product and research ideas to life. By combining precision engineering, innovativ ...
-
Quality Assurance Manager
3 weeks ago
SN&N Electronics Morgan Hill, United StatesCompany Description · SN&N Electronics, Inc. is a product development firm located in Morgan Hill, CA. We partner with technology startups, Fortune 500 companies, and academic institutions to bring product and research ideas to life. By combining precision engineering, innovative ...
-
Quality Assurance Manager
2 weeks ago
Total Aviation Staffing San Jose, United StatesWe are looking for a skilled and experienced Quality Manager to take charge of our client's quality assurance and control processes. As a Quality Manager, you will play a critical role in ensuring products meet the highest standards of quality. We want to hear from you if you hav ...
-
Sr. Quality Assurance Manager
3 weeks ago
Lumicity San Jose, United StatesThe ideal candidate comes with an extensive background in Quality Assurance/Engineering & Quality Management, specifically working from within the Medical Device industry. · Qualifications: · At least 9 years of Quality Assurance/Engineering experience working directly within the ...
-
Assurance Manager
2 weeks ago
Marcum LLP San Jose, United StatesMarcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your accounting career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-lea ...
-
Assurance Manager
2 weeks ago
Moss Adams LLP Campbell, United StatesAssurance Manager - Health Care · Description · At Moss Adams, we champion authenticity. For us, that means fostering a culture of talented people who care-about you, about our clients, and about our communities. Here, you'll work towards our mission of empowering others to emb ...
-
Senior Quality Assurance Manager
3 weeks ago
Connect Life Science San Jose, United StatesJob Title: Senior Quality Assurance Manager · Compensation: $150,000 - $200,000, plus Comprehensive Benefits and Stock Options · Industry: Medical Devices · Location: San Jose, CA · We are seeking a seasoned leader in the field of Medical Devices, equipped with an engineering ba ...
-
Sr. Manager, Quality Assurance
2 weeks ago
Minerva Surgical Inc Santa Clara, United StatesPOSITION SUMMARY: · The Sr. QA Manager leads a team of Quality Engineer(s), Document Control Specialist(s), and Quality Assurance Specialists. The Sr. QA Manager is responsible for overseeing: material release, batch record review, and finish product release; document control a ...
-
ISO9001 Quality Assurance Manager
2 weeks ago
iTest, Inc. Milpitas, United StatesJob Description · Job DescriptioniTest, Inc. is Silicon Valleys newest independent IC testing laboratory. iTest believes that a technically intensive business cannot and must not become a zero-sum game. It can be and must be the win-win equation of customers, suppliers, and emplo ...
-
Sr. Quality Assurance Manager
1 week ago
Lumicity San Jose, United StatesThe ideal candidate comes with an extensive background in Quality Assurance/Engineering & Quality Management, specifically working from within the Medical Device industry. · Qualifications: · At least 9 years of Quality Assurance/Engineering experience working directly within the ...
-
Sr. Manager, Quality Assurance
2 weeks ago
Minerva Surgical Santa Clara, United StatesJob Description · Job DescriptionPOSITION SUMMARY: · The Sr. QA Manager leads a team of Quality Engineer(s), Document Control Specialist(s), and Quality Assurance Specialists. The Sr. QA Manager is responsible for overseeing: material release, batch record review, and finish pro ...
-
Senior Manager Quality Assurance
2 weeks ago
Biocare Medical, LLC Pacheco, United StatesJob Description · Job DescriptionOur Company · Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market lead ...
-
Quality Assurance Ops Technical Manager
2 weeks ago
US Tech Solutions Sunnyvale, United States· Job Description:As a program manager, you will be responsible for quality assurance for a portfolio of workflows. · This includes everything from building out quality assurance processes, to monitoring the quality, to analyzing and addressing error trends. · Responsibilities:E ...
-
Manager of Quality Assurance
3 weeks ago
DeepSight Technology Santa Clara, United StatesDeepSight Technology Inc. is a stealth-mode startup company that has developed breakthrough technology in ultrasound imaging. This new technology will both extend the range and clarity over current systems by 10x - 100x We are setting new standards that will dramatically improve ...
-
Software Quality Assurance Program Manager
2 days ago
NVIDIA Santa Clara, United StatesDo you enjoy solving problems in a complex environment where you'll work with many different teams across NVIDIA? Are you a project manager that thrives working on product development? Do you like to work with multidisciplinary teams on the future of computing? Then we want to he ...
-
Clinical Quality Assurance Associate Manager
4 weeks ago
Ihealth Labs Inc Sunnyvale, United StatesJob Description · Job DescriptionWork Location: Sunnyvale, CA · Annual Pay Range: $80,000 - $120,000 · Job Type: Full-Time Onsite · Our Company:Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-conn ...
-
Quality Assurance Manager
2 weeks ago
Lumenous Device Technologies Santa Clara, United States**Lumenous is Hiring** · Lumenous Device Technologies is at the forefront of medical device manufacturing for ultraprecision medical components for interventional catheters, implants, robotic surgery, and a wide variety of components used in mínimally invasive medical devices thr ...
-
Nondestructive Testing Technician
1 week ago
RCG Moody International Limited c/- Intertek Morgan Hill, United StatesNondestructive Testing Technician (NDT) · Professional Service Industries, Inc. (Intertek-PSI) is looking for a Nondestructive Testing Technician (NDT) to join our Building & Construction team in Morgan Hill, CA . · Intertek-PSI is a leading US based provider of assurance, testin ...
-
Sr. Manager, Quality Assurance
4 weeks ago
Minerva Surgical Inc Santa Clara, United StatesPOSITION SUMMARY: The Sr. QA Manager leads a team of Quality Engineer(s), Document Control Specialist(s), and Quality Assurance Specialists. The Sr. QA Manager is responsible for overseeing: material release, batch record review, and finish product release; document control and t ...
-
Senior Quality Assurance Manager
3 weeks ago
BioTalent Santa Clara, United StatesJob Title: Senior Quality Assurance Manager · If your skills, experience, and qualifications match those in this job overview, do not delay your application. · Job Summary: The Senior Quality Assurance (QA) Manager is responsible for leading a team of Quality Engineers, Documen ...
Senior Quality Assurance Manager - Morgan Hill, United States - Sheathing Technologies Inc
3 weeks ago
Description
Senior Quality Assurance Manager
Sheathing Technologies, Inc., founded in 1992, is a medical device manufacturer of Ultrasound Probe Covers, FDA-Cleared Viral Barriers, Adhesives, Needle Guides Kits, Ultrasound Gel, and Storage/Transport Covers. We are the global leader of infectious control solutions. We are proud of the fact that more than 90% of our products are manufactured in the United States with the bulk of it right in our facility located in Morgan Hill, CA. As market leaders, our technological advancements for ultrasound procedures have enabled us to continually increase quality, year after year. We are looking to expand our team and are now accepting applications for a Senior Quality Assurance Manager.
If the following job requirements and experience match your skills, please ensure you apply promptly.
Our biggest accomplishment in recent history has been to develop and create the world's only FDA cleared Viral Barrier which provides the safest ultrasound guided procedures. This product provides our clinicians and their patients with a complete barrier to all bacteria and all currently known testable viruses.
Sheathing Technologies, Inc. is committed to providing a comprehensive benefits package to all of the company's employees. We offer standard benefits such as medical, dental and optional vision coverage, life insurance, 401(k) matching plan & tuition reimbursement. The benefits offered by Sheathing Technologies, Inc. is designed to positively impact all aspects of your life; to help you and your family succeed and to maintain our status as a "perfect job". Come find out what Sheathing Technologies, Inc. has to offer you.
As a Senior Quality Assurance Manager in our Morgan Hill, CA facility you will be responsible for:
· Maintaining the company's Quality Management System (QMS)
· Enforce compliance with global regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, UK Medical Device Regulations and EU MDD/MDR; Serving as Management Representative and/or Person Responsible for Regulatory Compliance (PRRC).
· Manage Quality Assurance & Supplier Quality processes within the QMS.
· Review manufacturing and testing documentation including validation/qualification, and other technical documents. Support final review and release of material produced in-house and at contract manufacturers.
· Host audits (Internal and Supplier/External). Manage audit schedules.
· Familiarity with using eQMS & ERP software.
· Provide Quality oversight for labeling, packaging, storage, and distribution of materials.
· Collaborate with functional groups to evaluate and address complex issues such as deviations, complaints, corrective, and preventative action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventative action (CAPA) recommendations related to products.
· Serve as a Quality Representative on new product development project teams.
· Provide oversight of environmental and bioburden testing activities of production areas (Class 8).
· Primary responsibility for the creation and maintenance of the Technical Files of Sheathing Technologies, Inc. product families for submission to Notified Bodies associated with the European Union (EU) and United Kingdom (UK).
· Provide input into strategic goals and identify and elevate gaps in current goals.
· Represents QA on cross functional teams and in interactions with other departments.
· Provides direction and oversight of the Risk Management Process per the requirements defined in ISO
· Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
· Has a Supervisory Role: A minimum of 10 years managing a team. Hires/terminates in coordination with HR, sets pay with CEO/President/COO/HR, mentors, advises, promotes, assigns, and evaluates work and performs yearly performance reviews.
Qualifications:
Salary: $137,500 to $164,000 commiserate with experience