• Sr. Staff Quality Specialist - Complaint Handling Jobs in United States Of America - 23790446

  • United States Of America, Usa
  • Save Job
  • 7 - 10 Years
  • Posted : above 1 month

Job Description:

Self-directed imitators People who take ownership of their work and need no prompting to drive productivity, change, and outcomes
Collaborative partners People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions
Goal-oriented developers Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions

What you will do

As a Senior Staff Quality Systems Specialist, you will lead the Integration and Sustainment of Complaint Handling as a Divisional Process Owner You will serve as subject matter expert for our organization to build understanding of quality concepts and drive our quality culture across newly acquired sites

Build capabilities within local sites, with the goal that they can serve as a divisional process owner for Complaint Handling for Medical Device, Pharmaceutical, Biocides and Cosmetic Products across the Medical division for key areas, such as Complaint Intake
Complaint Handling
Setting and performing against complaint metrics
Leading site process owners in process and regulation changes
Drive continuous improvement to the Complaint Handling processes

Represent the Medical Division on the Global Complaint Handling hub and spoke team to establish, implement, and maintain global Regulatory and Quality processes, documents, and systems supporting Strykers Global QMS Coordinate input, feedback, and represent Medical Divisions needs on the global hub & spoke team
Accountable for local process/system/training implementation

Provide input and prepare new acquisitions under Stryker Medical for the implementation of TrackWise as the software tool which is used to manage complaints electronically Support sites in the understanding of Complaint Handling in TrackWise
Work with sites to understand their plans to adapt and incrementally adjust local processes to lead to a successful new Complaing Handling adoption in TrackWise
Develop a plan to support sites in the TrackWise system
Facilitate recurring meetings with Complaint Handling site process owners, subject matter experts and management at sites within the Medical division to identify best practices and build a community of experts in this area

Connect with other Medical divisional process owners to integrate and improve connections to adjacent processes, as needed, to support the Complaint Handling process
Lead the representation of Quality Systems and Quality Processes which you own in External Audits and/or support local site process owners
Monitor compliance to Corporate Quality Procedures, FDA (and other) Quality System Regulations (QSRs) and update as necessary

What you need

Bachelors Degree Engineering preferred or related field
Minimum of 7 years of experience in Quality Systems or Quality Engineering
Experience 21 CFR Part 820, ISO-13485, EU MDR, MDSAP, and preferably training for ISO-14971, strongly preferred not required
Breadth of knowledge across the Medical Device Quality System, with a focus on pre and post-market activities (eg, Complaint Handling, Design & Development, Risk Management, Change Control, Document Control, Quality Planning) preferred not required
Manage projects in a timely manner, including ability to accurately assess resources, time and systems necessary to complete a project preferred not required
Project Management training and/or experience preferred not required

Work From Home No

Travel Percentage Up to 25 PERCENT

Stryker Corporation is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status Stryker is an EO employer M/F/Veteran/Disability

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Manufacturing/Industrial, Healthcare
Functional Area : Quality/Process Control
Role : Quality Assurance
Salary : As per Industry Standards
Deadline : 11th Apr 2020

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