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Manager, Design Quality, Lifecycle Management

TekWissen LLC

North Chicago, IL

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JOB DETAILS
SALARY
$90–$97
SKILLS
American Society for Quality (ASQ), Certified Quality Engineer (CQE), Change Control, Change Management, Code of Federal Regulations, Communication Skills, Contract Manufacturing, Corporate Policies, Corrective Action, Cross-Functional, Diversity, Document Management, FDA Requirements, ISO (International Organization for Standardization), Infusion Pumps, Internal Audit, Interpersonal Skills, Leadership, Management Strategy, Manufacturing, Medical Equipment, Medical Products, Mentoring, People Management, Policy Development, Problem Solving Skills, Process Improvement, Process Validation, Product Development, Product Strategy, Product/Service Launch, Project Design, Project Lifecycle, Project/Program Management, Quality Assurance, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Risk, Risk Management, Team Lead/Manager, Time Management, Traceability, Willing to Travel, Workforce Management
LOCATION
North Chicago, IL
POSTED
4 days ago
Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client is mission is to discover and deliver innovative medicines and solutions that address complex health issues and enhance people s lives.

Position: Manager, Design Quality Lifecycle Management
Location: North Chicago, IL 60085
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job Description:
Manager, Design Quality - Lifecycle Management
  • Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
  • Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc.
Responsibilities:
  • Primary driver for the quality and compliance aspects of product transfer and on-market change management.
  • Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.
  • Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV.
  • Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
  • Lead/support lifecycle design change projects following Design Control and Change Control principles
  • Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure.
  • Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
  • Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
  • Assist 3rd party suppliers during change management process, including change management strategies
  • Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
  • Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
  • Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
  • Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues
  • Establishes and maintains relationships and open communication with suppliers, contract manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
  • Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
  • Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents
  • Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc.
Qualifications:
  • Bachelor s degree in engineering, science, or other technical areas; Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.)
  • 8+ years of relevant experience in the medical device or combination product industry; 5+ years of Quality Assurance experience required.
  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)
  • Working knowledge of international standards and regulations applicable to medical devices and combination products
  • Experience with infusion pumps, PFS, Autoinjector, or On Body Injector preferred.
  • Ability to apply practical and technical problem solving to quality system and product improvements
  • Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.
  • Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.
  • Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives
  • Champions high quality deliverables, innovation, and appropriate risk-based decision making; Ability to understand the sensitivities within the AbbVie s environment.
  • Excellent project management and interpersonal skills
  • Adaptable to changes in work environment
  • Ability to work in a fast-paced environment
  • Able to travel up to 10% of the time.
What are the top 3-5 skills, experience or education required for this position:
  • Design Control Principles
  • Change Control Principles
  • Working knowledge of Medical Devices and Combination Products (MDCP), such as Infusion Pumps, On Body Injectors, PFS
  • FDA/EU regulations on MDCP
  • Applicable standards
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/

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