Integrated DNA Job - 43328369 | CareerArc
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Company: Integrated DNA
Location: Coralville, IA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

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: Manager of Complaints and Nonconforming Processes

Location: Coralville, IA ​*Mobile/Remote (On-Site/Work from Home Hybrid)*

-Mobile associates must live in an area that does not exceed a 100-mile (150 km) radius of an IDT location. *May require on-site occasional presence for team meetings, etc.

Purpose Statement:

The Manager of Complaints and Nonconforming Processes-Coralville, provides support and assists in management of the Quality Assurance program including customer complaints and nonconformances within the Coralville, Iowa location.  Other functions will include: [1] responsible for establishing and overseeing Quality Events and supporting day to day activities of the complaint and nonconformance teams, [2] accountable to ensure compliance with ISO 13485:2016, ISO 9001:2015 and with internal processes and procedures.  Responsibilities may also include performing in the role of liaison with external and cross-functional internal parties on matters relating to quality concerns and driving continuous quality excellence as well as prompt resolution of issues.

                                                                                                                               

Job Specific Duties/Essential Functions:

  • Primarily maintains overview of complaint and nonconformance QMS activities.

  • Lead a team that is responsible for capturing, investigating, and closing complaints and non-conformances.

  • Provide mentorship and expertise for the compliant and nonconformance coordinators and foster a culture of learning by motivating, inspiring, coaching and developing team members.

  • Use established management skills to lead teams to achieve quality compliance and business objectives.

  • Reviews and approves local in-process and completed quality event records as well as SOPs for accuracy and completeness.

  • Development, review and reporting of complaint and nonconformance reports of quality system performance and KPIs for internal department use as well as management review meetings.

  • Maintains an up-to-date knowledge of and provides expertise in the areas of QA compliance to ISO 13485:2016 and ISO 9001:2015 requirements. 

  • Interacts professionally and efficiently with global QMS staff and provides recommendations for collaboration on improvement efforts.

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

  • Performs special projects and other duties as assigned.

Education, Licensure, Certification, Registration:

  • Bachelor's degree is required (science-related field is preferred)

  • 5+ years of experience supporting a Quality Management System in a related industry

  • Experience managing and developing a team

Professional Experience:

  • Excellent understanding of regulations and standards such as: 21 CFR 820, ISO 13485, ISO 9001, or similar standards/regulations.

  • Experienced with Quality tools, methodologies, and complaint investigations, including root cause analysis

  • Experience with creation and implementation of QMS standard work, required. 

  • Experience with Master Control is a plus

Other Knowledge, Skills, and Abilities:

  • 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).

  • Comfortable in a role of authority and guidance on QMS requirements. 

  • Ability to drive initiatives to a successful conclusion.

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 80,000 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 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.



Responsibilities

Job Title: Manager of Complaints and Nonconforming Processes. May require on-site occasional presence for team meetings, etc. The Manager of Complaints and Nonconforming Processes-Coralville, provides support and assists in management of the Quality Assurance program including customer complaints and nonconformances within the Coralville, Iowa location. Other functions will include: [1] responsible for establishing and overseeing Quality Events and supporting day to day activities of the complaint and nonconformance teams, [2] accountable to ensure compliance with ISO 13485:2016, ISO 9001:2015 and with internal processes and procedures. Responsibilities may also include performing in the role of liaison with external and cross-functional internal parties on matters relating to quality concerns and driving continuous quality excellence as well as prompt resolution of issues. Primarily maintains overview of complaint and nonconformance QMS activities. Lead a team that is responsible for capturing, investigating, and closing complaints and non-conformances. Provide mentorship and expertise for the compliant and nonconformance coordinators and foster a culture of learning by motivating, inspiring, coaching and developing team members. Use established management skills to lead teams to achieve quality compliance and business objectives. Reviews and approves local in-process and completed quality event records as well as SOPs for accuracy and completeness. Development, review and reporting of complaint and nonconformance reports of quality system performance and KPIs for internal department use as well as management review meetings. Maintains an up-to-date knowledge of and provides expertise in the areas of QA compliance to ISO 13485:2016 and ISO 9001:2015 requirements. Interacts professionally and efficiently with global QMS staff and provides recommendations for collaboration on improvement efforts. Demonstrates behavior consistent with the Integrated DNA Technologies Core Values. Performs special projects and other duties as assigned.


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