- 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 14971.
- Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
- Has a
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Senior Quality Assurance Manager - Morgan Hill, United States - Sheathing Technologies Inc
3 weeks ago
Description
Senior Quality Assurance ManagerSheathing 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.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:
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:
Bachelor's Degree in a relevant scientific, or engineering discipline with 10+ years of demonstrated QA experience in a medical device firm.
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.
Salary:
$137,500 to $164,000 commiserate with experience
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