Quality Assurance Manager – Quality/Regulatory – Cedar Creek

Interested applicants should go to this link to apply.

Job Title: Quality Assurance Manager
Description: Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek –– so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

The Quality Assurance Manager will play a key role with our new product introduction team for genomics products that are taken from concept, design, development to commercialization. The genomics and genetic testing products consist of reagents, microarrays, instruments and bioinformatics software. The QA Manager will ensure compliance with industry guidelines, regulatory standards and company requirements. Responsibilities will also include interfacing with team members such as Marketing, R&D, Manufacturing, Support and Clinical as well as outside organizations such as suppliers, test facilities and regulatory bodies
1. Develops, implements and maintains Quality Management system and activities within FDA, ISO 13485 and international regulatory guidelines.
2. Serves as site management representative with responsibility for reporting on the performance of the quality system and any need for improvement to top management.
3. Serve as the quality representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required.
4. Lead a team of QA engineers for design, development and commercialization of new genomics products.
5. Develops, modifies and executes regulatory related company guidelines and procedures.
6. Evaluates contract manufacturer(s) to meet the company’s quality requirements
7. Conducts internal Quality Assurance compliance audits and communicates results.
8. Interfaces with external auditing entities and communicates results
9. Ensures the promotion of awareness of customer, quality and regulatory requirements throughout the organization
10. Interpret Regulatory Authority policies, guidance and correctly applies them as appropriate in product development.
11. Assist in RA filings (Pre-sub, IDE, PMA, 510k, design dossiers) to promote successful product regulatory submissions and increase probability of regulatory approval.
12. Assist in development and execution of regulatory plans for complex projects. Assist in documentation for regulatory meetings with FDA.
13. Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards
14. Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
15. Review and approve change requests and Change Orders.
16. Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D to confirm experimental design conforms to appropriate regulatory requirements.
17. Create and / or update design and process FMEA. Review, create, and / or update traceability matrices
18. Conduct detailed reviews of all design history files; coordinate with project management, R&D, and manufacturing as needed ensure the project deliverables are complete, accurate, and in compliance with regulatory requirements. Identify gaps and update Design History Folders (DHF) and Device Master Records (DMR) for the existing products.
19. As needed, coordinate with production manufacturing to bring device master record documentation to QSR levels.
20. Provide quality and regulatory training to company staff

Qualifications: Educational Requirements:

1. Bachelors or Master’s Degree or equivalent in Biological science or equivalent work experience
2. 5+ years’ experience in a biological manufacturing environment. Must have prior experience with wet lab bench work. Prior experience with next generation sequencing is preferred.
3. Solid understanding of medical device design control and regulations as well as quality management standards (ISO 13485, FDA 21 CFR part 820, EU Medical regulations, Canadian Medical Device regulation), ISO 14971, IEC 60601, 62304, 62366.
4. Knowledge of next generation sequencing assay workflow and associated product is highly desirable.
5. Strong oral, written and communication skills; including strong negotiation skills. Excellent interpersonal and presentation skills
6. Must have 3+ years of hands on experience writing and executing validation protocols and reports for the medical device industry.
7. Understanding of how to work quickly in a regulated environment establishing processes for integration of revision control, validation, and implementation of changes.
8. Experience with bioinformatics and statistical design is greatly preferred.
9. Proficient in Microsoft office suite required. Experience using bioinformatics data analysis software is preferred.
10. Travel time is around 5 – 10%.

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster available here:
https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf,

https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-754-5030 (US and Canada only) or email job_posting@agilent.com. EOE AA M/F/Vet/Disability

Company:
Business: Diagnostics and Genomics Group
Job Category: Quality/Regulatory
Job Sub-Category: Quality/Regulatory Mgmt
Region: Americas
Country or Area: United States
State/Province: Texas
Town/City: Cedar Creek
Shift: Day Job
Job Type: Experienced
Schedule: Full-time
Travel Required: Yes, 10% of the Time
Duration
(Temp Positions Only):
Not applicable
HR Country Location: United States
HR Town/City Location : Cedar Creek

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