- With Growth Comes OpportunityCutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint.
-
Manager, Quality Assurance
3 weeks ago
Cutera Brisbane, United States**Company Description** · We're Growing - With Growth Comes Opportunity · **Job Description** Position Summary**: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to m ...
-
Director, Quality Assurance
3 days ago
Cellares South San Francisco, United StatesWe are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and c ...
-
Quality Assurance
3 weeks ago
University of California San Francisco San Francisco, United StatesThe Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization's products and/or development processes. QA deliverables and mana ...
-
Quality Assurance Manager
2 weeks ago
Bayview Hunters Point Foundation for Community Imp San Francisco, United States**What We Do**: · Bayview Hunters Point Foundation has been at the heart of social justice for over 50 years, providing support services for predominantly low-income people of color in the Bayview and throughout San Francisco. · Our mission is to build a community that is empower ...
-
Quality Assurance Manager
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. · • Partners ...
-
Quality Assurance Specialist
2 weeks ago
Actalent San Mateo, United States Full timeDescription: · Role and Responsibilities: · • Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements. · • Review executed productio ...
-
Quality Assurance Manager
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub functions. · • Partners ...
-
Quality Assurance Specialist
2 weeks ago
Actalent San Mateo, United States Full timeDescription: · 20% BRR · 80% Analytical focused · • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements · • Serves as QA Lead for clinical and commercial projects. · • Leads quality investigations/deviations/ ...
-
Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeQuality Assurance Specialist · HYBRID role, onsite in Foster City, CA · Description: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilanc ...
-
Quality Assurance Tech I
3 weeks ago
Intelliswift Software, Inc. San Francisco, United StatesPay rate range - $40/hr. to $42/hr. on W2 · ** Must Have** · Able to run test cases without running into issues · able to find bugs/ resolve bugs · Able to follow a release checklist/identify task · Requirement · - Also looking to have very hands-on knowledge of QA processes: · W ...
-
Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients · • Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations · • ...
-
Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaint from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to the Pharmacovigilance Department. Performs or provides support for product complaint investigations · ...
-
Quality Assurance Specialist
2 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investi ...
-
Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for Gilead products from the US and Canadian markets.Documents in Gilead Quality System for investigation for product complaints and triages safety events to Gilead Pharmacovigilance Department. Performs or provides support for product ...
-
Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. · Performs or provides support for product complaint inve ...
-
Quality Assurance Technician
1 week ago
Petit Pot Emeryville, United StatesAbout Petit Pot · In 2014, while trying to find the perfect dessert to go with dinner, French pastry chef Maxime realized something was missing in his local grocery store: Pot de crème As a fan of all things sweet, Maxime decided to address this craving by founding Petit Pot in S ...
-
Manager, Quality Assurance
1 day ago
Cutera Brisbane, United States PermanentJob Description · Position Summary: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to market devices. Additionally, the individual is responsible for the assessment ...
-
Manager, Quality Assurance
3 weeks ago
Cutera Brisbane, United StatesCompany Description · We're Growing - With Growth Comes Opportunity · Cutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right per ...
-
Manager, Quality Assurance
2 weeks ago
Cutera Brisbane, United StatesCompany Description · We're Growing - With Growth Comes Opportunity · Cutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right per ...
-
Manager Quality Assurance
6 days ago
Biogen Brisbane, United StatesJob Description · Position Summary: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to market devices. Additionally, the individual is responsible for the assessmen ...
Manager, Quality Assurance - Brisbane, United States - Cutera
Description
Company DescriptionWe're GrowingRead more at Company's technology enables physicians to provide advanced solutions for a broad range of medical aesthetic applications including improving the skin's appearance through the treatment of superficial benign vascular and pigmented lesions, unwanted hair removal, improvement in skin laxity and wrinkles, and body contouring and sculpting.
Job DescriptionPosition Summary:
The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to market devices.
Additionally, the individual is responsible for the assessment of device changes for quality and regulatory implications and developing strategies for submissions and maintenance of documentation within the framework of regulatory requirements in an efficient manner.
Duties and Responsibilities:
Manage and maintain Cutera's Quality System to ensure continued compliance with global regulatory and customer requirements.
Lead and manage Cutera's Quality Assurance department and employees to achieve organizational goals and employee development and growth.
Promote the recognition of quality programs within the company to create a shared continuous improvement mindset across functional departments.
Prepare and maintain organizational readiness for FDA, ISO and other agency audits of our quality system.
Lead and manage compliance processes (CAPA, Internal Audit, Material Review board, Supplier Quality) and implement improvements.
Formulate, document and maintain quality metrics and on-going objectives.
Serve as a Lead Auditor, develop and manage internal audit systems, address non-conformities from internal and external audits.
Oversee calibration and testing systems.
Participate and provide input into the design and development of new products, including risk analysis and quality planning to transition new products to production.
Participate in supplier qualification and oversight, including perform supplier audits.Train and support manufacturing personnel on quality system requirements, and safety and hazardous material handling processes.
Maintain compliance with FDA, GMP/QSR, Manufacturing process/Work Instructions and ISO 13485.Other duties as assigned.
QualificationsPosition Requirements:
Master's or Bachelor's degree in a technical field, or equivalent experience with a minimum of 5+ years of experience with Quality System Management for an ISO certified Technology Company (medical device or electronics devices preferred).Extensive knowledge of ISO 13485 compliance.
Experience in quality planning, project management, verification, validation, and process validation.Strong organizational skills and high-quality standardsHands on ability to lead a group of individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team.
Ability to link functional responsibilities to overall business goals, and to manage and prioritize multiple projects simultaneously. Previous experience mentoring and training staff is preferred.Proficient in use of MSWord, Excel, PowerPoint and other technical tools for QMS / PLM management is required.
Strong writing skills and formatting skills.
Ability to work well under pressure while managing multiple projects and meeting deadlines.
Provide detailed reports to Senior Management on critical projects as well as provide quarterly updates to the BoD.Ability to read and understand regulations, standards and procedures.
Good leadership, analytical and interpersonal skills.Travel of 5 to 10% possibleAdditional InformationCutera expects to reasonably pay in the range listed below for this position based on the city and state listed in the job posting:
Annual base salary:
$120,000 - $150,000The actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, education, and candidate residence if the position is remote or field-based. We reserve the option to pay above this range for exemplary experience or higher education.
All your information will be kept confidential according to EEO guidelines.
If you are ready to become part of our spectacular, growing, and FUN company, then apply todayWe are an equal opportunity employer and value diversity at our company.
We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment.
Please contact us to request accommodation.Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.
Videos To
