Specialist, Post Market Quality

4 weeks ago

Portage, United States Stryker Corporation Full time

**Why RA/QA at Stryker?**:
Stryker is hiring a **Specialist, Post Market Quality** **(Hybrid) **in **Portage, MI** supporting **Instruments** In this role, you will support to the Post-Market Quality team that is responsible for both domestic and international complaint handling along with the product field action team. Specifically, this position is responsible for the coordination of material and information to meet quality and regulatory requirements.

**Work Flexibility**: Hybrid. This role requires reasonable proximity to our Stryker facility in Portage, MI. You should be comfortable working 3-days onsite.

**Who we want**
- ** Dedicated achievers.** People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- ** Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- ** Self-directed imitators.** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

**What you will do**
- Participation in product field action strategy meetings.
- Creation and mailing of customer letters for product field action notification.
- Communicate directly with customers to perform product field action effectiveness checks on open actions.
- Coordination with customer care teams on replacement products and credits.
- Communicate with internal and external resources globally on product field action execution activities.
- Provide updates within Trackwise on status of product field action executions.
- Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with customers and sales teams.
- Provide updates within Trackwise on status of event detail information and product returns to support complaint handling activities.
- Work with internal and external partners on the facilitation of movement of complaint return product.
- May support international and domestic complaint entry.
- Support management with various weekly, monthly and quarterly reporting as needed.
- Work with internal supporting teams on quality of data coming into post market.
- May monitor, create and assign regulatory communications to quality specialists for resolution.
- Involvement in team projects as requested.

**What you need**

**Required**:

- Bachelor’s Degree required. Preferred to be in Engineering, Science, or related discipline.
- 0+ years of related experience.

**Preferred**:

- MS in Regulatory Science or Regulatory Affairs Certification (RAC) preferred.
- Basic understanding of how to comply with constantly changing regulatory procedures preferred.
- Develop basic knowledge and understanding of complaint handling and product field action process as required by regulatory agencies.

**About Stryker**:
**Our benefits**:

- 12 paid holidays annually
- Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
- Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

**About Stryker**

**Know someone at Stryker?**

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.

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