Quality Assurance Supervisor

Company: Cepheid
Location: Sunnyvale
Posted on: November 16, 2021

Job Description:

Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. -May conduct quality assurance tests to ensure product specifications are met. -May review, investigate, resolve and report on quality discrepancies. -May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. -May monitor, investigate, and report on customer complaints. -May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities.

Shift: Mon-Fri 6 am -2:30 pm

PRIMARY RESPONSIBILITIES:
Responsible for prioritization of daily QA activities to ensure batch record and document releases are met .
Review batch records and documents, for completeness and compliance with QSR and ISO requirements to support release of raw materials, work in progress and final products. This includes components, consumables, reagents, components, and instrumentation-related products.
Train and supervise QA personnel to support QA release activities .
Address deficiencies and ensure completion of follow-up actions, specifically those that target process fixes to maintain consistent resolution to all batch review issues according to GMP standards.
Positive interaction with internal Associates to resolve issues quickly and effectively.
Manage and support Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.

MINIMUM REQUIREMENTS:
Education or Experience:
Bachelo r s degree i n scientific , quality system , or related discipline, wit h minimum 8 years of quality related experienc e i n a regulated manufacturing environment or Master degree i n scientific , quality system , or related discipline, wit h minimum 4 years of quality related experienc e i n a regulated manufacturing environment .

Knowledge and skills:
Effective problem solving, analytical and organizational skills
Solid understanding of technical processes, DHR requirements, and inspection and testing processes.
Advanced experience with risk management and design control principles

PREFERRED QUALIFICATIONS :
Experience in DNA diagnostics or other medical devices
Certified Quality Engineer, Certified Quality Auditor or similar certification.
Knowledge of quality and manufacturing processes and methods

PHYSICAL DEMANDS
Ability to work in an office environment

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. - Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.

Keywords: Cepheid, Sunnyvale , Quality Assurance Supervisor, Other , Sunnyvale, California