Quality Assurance Supervisor
Posted on: November 16, 2021
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
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
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
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.
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
PREFERRED QUALIFICATIONS :
Experience in DNA diagnostics or other medical devices
Certified Quality Engineer, Certified Quality Auditor or similar
Knowledge of quality and manufacturing processes and methods
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
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
email@example.com to request accommodation.
If you've ever wondered what's within you, there's no better time
to find out.
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