Quality Engineer I

Fusion Life Sciences; Town of Texas (WI); On-site; USD 114,616,000 - 120,347,000; Full time

Job summary

Zimmer Biomet is seeking a Quality Engineer I to support product and process quality activities in a manufacturing setting. This entry-level role ensures conformance to requirements and quality standards through audits, inspections, testing, and evaluations.

You will collaborate with multiple departments and suppliers to uphold Zimmer Biomet’s quality objectives and product integrity. The successful candidate will contribute to CAPA development, data analysis, and continuous improvement

Qualifications

• 2+ years of relevant Quality Engineering experience.
• Bachelor’s degree in Engineering or equivalent with CQE certification.
• Experience supporting quality systems and product/engineering quality activities.
• Basic understanding of QSR and ISO requirements.
• Ability to work in a cross-functional team and meet deadlines.

Responsibilities

• Formulate procedures, specifications, and standards for products and processes.
• Develop and implement CAPA plans.
• Collect, evaluate, and analyze data for gauge and product evaluation.
• Support identification of components and materials for new products.
• Ensure suppliers have necessary information to deliver quality products.
• Support quality through audit, inspection, and testing activities.
• Collaborate with cross-functional teams to resolve quality issues.

Skills

Quality Engineering

Team collaboration

Deadline management

Communication skills

Problem solving

Education

Engineering degree

CQE certification

Tools

CMM

Optical comparators

MS Office

Job description

Quality Engineer I

Job ID: 37583552
Client: Zimmer Biomet
Location: Warsaw, IN
Work Arrangement: Onsite
Contract Duration: 6 Months
Pay Rate: $40 $42/hr on W2
Interview Process: Phone + In-Person
Candidate Location: Local candidates only
Relocation: Not accepted
Work Authorization: Any valid work authorization
Submission Deadline: EOD
Submission Slots: 3

Position Overview

Zimmer Biomet is seeking a Quality Engineer I to support product and process quality activities in a manufacturing environment. This is an entry-level Quality Engineering position responsible for ensuring that products conform to established requirements, specifications, and quality standards through appropriate audit, inspection, testing, and evaluation activities.

The Quality Engineer will interact with multiple functional departments, suppliers, and external experts to support and implement Zimmer Biomet's quality objectives and ensure consistent product quality.

Principal Duties and Responsibilities

• Formulate procedures, specifications, and standards for Zimmer Biomet products and manufacturing processes.
• Develop and implement Corrective and Preventive Action (CAPA) plans.
• Collect, evaluate, and analyze data for gauge and product evaluation activities.
• Support the identification of critical personnel, gauges, procedures, and materials required for the successful completion and introduction of new products.
• Ensure suppliers have the necessary information, specifications, and facilities required to deliver quality products to Zimmer Biomet.
• Support product quality through appropriate audit, inspection, and testing activities.
• Work collaboratively with cross-functional teams to resolve quality-related issues.
• Build effective relationships with internal departments, suppliers, regulatory agencies, and external stakeholders.
• Support continuous improvement initiatives related to product and process quality.
• Ensure quality activities are completed within established timelines and project requirements.

This is not an exhaustive list of duties or functions and may not necessarily comprise all essential functions for purposes of the Americans with Disabilities Act.

Required Qualifications

• Minimum 2+ years of relevant Quality Engineering experience.
• Bachelor's degree in Engineering or an alternative Bachelor's degree program with certification as a Quality Engineer, such as CQE (Certified Quality Engineer).
• Experience supporting quality systems, product quality, manufacturing quality, or engineering quality activities.
• Basic understanding of quality regulations and standards, including QSR and ISO requirements.
• Ability to work effectively in a team environment and collaborate with multiple functional departments.
• Strong written and verbal communication skills.
• Ability to manage deadlines and demonstrate a strong results-oriented approach.

Technical Skills and Competencies

The ideal candidate should have knowledge or experience in the following areas:

• Quality procedures, specifications, and standards
• Corrective and Preventive Action (CAPA)
• Gauge and product evaluation
• Data collection and analysis
• Product inspection and testing
• Blueprint reading
• Geometric Dimensioning and Tolerancing (GD&T)
• Basic understanding of QSR/ISO regulations
• Design Assurance principles
• Failure Mode and Effects Analysis (FMEA)
• Product testing methods
• Optical comparators
• Coordinate Measuring Machines (CMM)
• Microsoft Office Suite

Preferred Qualifications

The following qualifications are preferred but not required:

• Certified Quality Engineer (CQE) certification.
• Previous experience within the Medical Device industry.
• Experience supporting Orthopedic medical device products.
• Experience working with regulated manufacturing environments.
• Familiarity with supplier quality and supplier management activities.

Key Competencies

• Ability to work effectively within a team environment.
• Strong relationship-building skills with internal teams and external suppliers.
• Ability to communicate effectively with multiple levels of the organization.
• Strong attention to detail and analytical skills.
• Ability to meet deadlines and deliver results.
• Demonstrates strong potential for professional growth and future development opportunities.

Interview Process

1. Phone Interview
2. In-Person Interview

Important Candidate Requirements

• Local candidates only Warsaw, IN area
• Onsite availability is mandatory
• No relocation
• Candidates must be available to complete the interview process, including the in-person interview
• Medical Device and Orthopedic industry experience is strongly preferred