Complaint Specialist (Hybrid)

Portage, WI - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

Join Strykers Instruments Division in Portage MI as a Complaint Specialist where your work will directly support patient safety and product quality around the this highimpact role you will transform complex product events into clear regulatory actions that help protect patients clinicians and our brand. This is an opportunity to grow your expertise in postmarket surveillance within a collaborative missiondriven environment.

What You Will Do

Review and assess incoming product complaints to determine reportability in accordance with MDR MIR and global regulatory requirements.
Prepare and submit wellwritten adverse event reports within required timeframes to regulatory authorities.
Develop clear datadriven rationales for nonreportable events using risk documentation product knowledge and clinical input.
Conduct customer followup to obtain missing complaint details and coordinate product returns for analysis.
Initiate nonconformance records in the electronic quality system and maintain documentation accuracy for all complaint files.
Analyze complaint data to identify trends recurring failure modes and potential patient impact.
Investigate device performance by reviewing product design manufacturing history and related failures.
Respond to requests for additional information from global regulatory agencies in partnership with senior staff.
Support internal and external regulatory audits through timely documentation and subjectmatter insights.
Contribute to postmarket activities including recall assessments recall communications and product quarantine management.

What You Need

Bachelors degree (B.S. or B.A.) required.
0 years of relevant work experience required.

Travel Percentage: 10%

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.

Required Experience:

Work Flexibility: HybridJoin Strykers Instruments Division in Portage MI as a Complaint Specialist where your work will directly support patient safety and product quality around the this highimpact role you will transform complex product events into clear regulatory actions that help protect patie...

Work Flexibility: Hybrid

What You Will Do

Review and assess incoming product complaints to determine reportability in accordance with MDR MIR and global regulatory requirements.
Prepare and submit wellwritten adverse event reports within required timeframes to regulatory authorities.
Develop clear datadriven rationales for nonreportable events using risk documentation product knowledge and clinical input.
Conduct customer followup to obtain missing complaint details and coordinate product returns for analysis.
Initiate nonconformance records in the electronic quality system and maintain documentation accuracy for all complaint files.
Analyze complaint data to identify trends recurring failure modes and potential patient impact.
Investigate device performance by reviewing product design manufacturing history and related failures.
Respond to requests for additional information from global regulatory agencies in partnership with senior staff.
Support internal and external regulatory audits through timely documentation and subjectmatter insights.
Contribute to postmarket activities including recall assessments recall communications and product quarantine management.

What You Need

Bachelors degree (B.S. or B.A.) required.
0 years of relevant work experience required.

Travel Percentage: 10%

Required Experience:

Key Skills

Sales Experience
Crane
Customer Service
Communication skills
Heavy Equipment Operation
Microsoft Word
Case Management
OSHA
Team Management
Catheterization
Microsoft Outlook Calendar
EHS

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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