Job Description

Who we want:

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

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.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Stryker is hiring a Quality Assurance Engineer in Kalamazoo, MI.

As a Quality Assurance Engineer, you will be responsible for complaint handling, reliability improvement, quality management, quality systems, continuous improvement, quality systems engineering, project management and regulatory compliance. You will know and apply the fundamental concepts, practices and procedures of the quality specialization.

Essential Duties & Responsibilities

* Deliver exceptional customer service to compliant originator
* Resolve Potential MDR Investigations < 25 Days
* Close Complaint Investigations < 60 Days
* Champion Root Cause Problem Solving
* Perform Risk Analysis and Reduction
* Author Quality / Regulatory Technical Reports (QRTRs)
* Lead Customer Contact Phone calls, letters, visits
* Draft monthly bulletins to Field Service Reps on the status of quality and improvements made
* Reliability Improvement
* Trend service reports to identify top product issues and drive resolution
* Quality Management/ Quality Systems / Continuous Improvement
* Support Operations Ongoing support of critical quality issues as needed (ex: ship hold)
* Lead Quality Planning Create and drive Quality Plan for Business Unit with COE Quality Leader
* Business Unit Highlights Monthly data analysis and trending to support Quality Plan (ex: prep data)
* Statistical Support Lead Sample size selection, SPC, DOE, etc.
* Support SQEs (as needed)
* Material Review Board (MRB)
* Fabrication Tooling Certification, Gage Plans, Gage R&R, Validation Support
* Vendor Management Identify vendor quality issues and drive improvements
* Cost Reduction Team Support Support initiatives as needed
* Special Projects As needed by Business Unit and Department
* Support ECO & CAPA processes to ensure thorough and robust outcomes and enforce quality compliance (ex: Gage plans, FA, etc)
* Lead Quality centric problem solving 8Ds and CAPAs
* Quality Systems Engineering & Project Management
* Identify opportunities for enhancement of existing quality and regulatory systems/tools in support of our departmental and divisional visions.
* Provide quality support as a consultant to our organization to build understanding of quality concepts and drive our quality culture.
* Support AQEs (as needed):
* Provide engineering specification and product design support to R&D teams through robust design practices (GD&T, etc.)
* Participate in drawing development
* Develop control plans and inspection procedures
* Support GR&R with Metrology Specialist & AQT
* Participate in new product development process acting as a feedback loop from the field
* Regulatory Compliance
* Conduct Monthly Spider Web Audits and Quarterly Team Audits as required
* Participate in internal compliance audits FDA, ISO, and Internal Audits
* Support external audits Vendor and Sister Divisions
* Monitor compliance to Medical Quality Procedures and FDA Quality System Regulations (QSRs) and update as necessary
* Regulatory Training Conduct and support training on QSRs, ISO, and RA Topics
* Monitor the ECO & CAPA processes meet all compliance requirements (ex: Write it Right!)

What you will need:

Basic Qualifications

* Bachelors Degree in Engineering or completion of Engineering degree by June 1, 2021

Preferred Qualifications

* GPA of 3.0 or higher, strongly preferred
* Achieved a limited (learning) level of industry knowledge
* Competent with Microsoft Office (Outlook, Excel, Word, etc.)
* Must possess excellent oral and written communication skills
* Ability to solve problems in a high stress situation
* Possess attention to detail
* Eagerness to assist internal and external customers
* Manage projects in a timely manner
* Ability to conduct and document technical investigation
* Experience with Statistical Analysis, highly desirable