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Danaher Corporation Quality Systems Validation Engineer in Coralville, Iowa

IDT is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Job Title: Quality Systems Validation Engineer

Location: Coralville, IA

Purpose statement:

The QS Validation Engineer is responsible for providing leadership to administration, technical review, investigations, and improvements within the IDT Quality System program to ensure compliance with established internal policies, FDA, and ISO regulations.

This role is accountable to ensure accurate and timely completion of IDT Quality Systems records related to the manufacturing processes. This role provides leadership to general IDT quality systems activities including change control, deviation, risk management, complaints, non-conformances, and root cause investigation.

Essential Functions:

  • Coordinate projects for Quality System improvements and provide direction for team members to deliver documented activities and reports.

  • Represent QA by collaborating on teams focusing on controls, process transfer, validation, monitoring and risk management.

  • Perform detailed review and provide input for Quality System forms for IQ/OQ/PQ of manufacturing process, equipment, methods and prepare reports for Quality System Performance and validation gap assessments.

  • Review and improve strategies, processes, and templates for application of risk-based Quality System activities including validation (IQ, OQ, PQ) of new products, processes, equipment, and methods.

  • Interacts professionally and efficiently with global manufacturing and support staff and provide recommendations for risk-based change control within the electronic QMS software (Master Control).

  • Provide leadership to assist with root cause investigation and closure of non-conformances / complaints and CAPAs related to the manufacture of IDT products.

  • Assist with the development and QA review of validation planning documentation to ensure compliance with IDT QA policy, ISO 9001, ISO13485, and 21CFR Part 820 FDA Quality System expectations.

  • Performs activities and tasks assigned as part of QA based improvement initiatives and projects.

  • Participate in documentation of general risk management process records including FMEA in compliance with ISO 14971.

  • Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.

  • Performs other duties as assigned.

Education:

  • Bachelor’s degree in engineering or science related field required (or equivalent experience).

Professional Experience:

  • 3-5 years of experience and familiarity with Quality System requirements to meet compliance with ISO 13485 standards and FDA QSR/cGMP standards, required

  • 3 years of experience and familiarity with risk-based (FMEA) investigation, validation, and change control systems, within a regulated industry, required

  • Experience and familiarity with Lean manufacturing principles, preferred

Skills:

  • Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.

  • Comfortable with learning advanced calculations and reporting with Microsoft Office applications (emphasis in Excel, Word, PowerPoint).

  • Statistical analysis, precision measurement, and process capability studies will become an intricate part of quality assurance programs; therefore, formal education in courses related to these areas such as mathematics, statistics, and industrial practices, may be essential for this position.

Other Job Qualifications:

  • Ability to perform a variety of duties, often changing from one task to another without loss of efficiency or composure.

  • Ability to maintain both a high standard of courtesy and cooperation in dealing with co-workers.

  • Ability to perform repetitive work or to perform continuously the same work, according to set procedures sequence or pace.

Travel Requirements:

  • Seldom = up to 5% of the time

Physical Requirements:

Exert up to 10 lbs. of force occasionally and/or up to a minimal amount frequently

Constant (67%-100% of work day)

  • Reaching: extending hand(s) and arm(s) in any direction.

  • Sitting: to assume a position in which the weight is largely supported by the buttocks, usually with the body vertical and the thighs horizontal.

  • Using Fingers/Grasping/Feeling: writing or otherwise working, primarily with fingers rather than with the whole hand or arm as in handling. Applying pressure to an object with the fingers or palm and perceiving attributes of objects such as size, shape, temperature or texture by touch.

  • Hearing: perceiving the nature of sounds at normal range; ability to receive detailed information through oral communication, and to make fine discriminations in sound, such as when auscultating and percussing.

  • Repetitive Motion : substantial movements (motion) of the wrists, hands, and/or fingers.

Frequent (34-66% of work day)

  • Talking: expressing or exchanging ideas by means of the spoken work- those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.

Occasional (33% or less of work day)

  • Standing : maintaining an upright position.

  • Walking : moving about on foot to accomplish tasks.

  • Lifting : raising objects from a lower to a higher position or moving objects horizontally from position to position.

  • Bending : bending body downward and forward by bending spine at the waist and/or bending leg; bending legs at knee to come to rest or kneel.

  • Pushing/Pulling : using upper extremities to press against something with steady force in order to thrust forward, downward or outward/using upper extremities to exert force in order to drag, haul or tug objects in a sustained motion.

  • Climbing : stairs, stools, ramps, ladders.

Visual Acuity:

  • Work requires close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.

  • Ability to read pertinent printed material and distinguish colors.

  • Ability to accurately read measurements on equipment.

  • Ability to prepare and read written documentation; use of computer.

What We Offer:

  • Generous Paid Time Off Accruals

  • 16 Hours PAID Volunteer Time Off

  • 10 Paid Holidays

  • Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates

  • 401(k) with Company Match

  • Medical, Dental, and Vision Insurance Options

Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.

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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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 (https://www.dol.gov/agencies/ofccp/posters) .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.

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