Quality Engineer

Pay Range: $40 to $44.5/hr.

Job Description: 100% onsite
Shift - 8 AM 4:30 PM

Job Purpose

Develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet BSC, customer, and regulatory requirements. Serves as a Quality representative to enhance awareness, visibility, and communication related to quality initiatives supporting departmental, functional, site, divisional, and corporate quality goals.

Provides dedicated quality engineering support across new product development, operations, and system/services functions.

Functional Engineering Roles include:
Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiology, Chemistry.

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Key Responsibilities

1. Identify and implement effective process control systems to support development, qualification, and ongoing manufacturing of products meeting internal and external requirements.
2. Lead implementation of assurance programs, process controls, and CAPA systems aligned with regulatory and internal expectations.
3. Act as an effective leader or team member to support quality disciplines, decisions, and best practices.
4. Apply systematic problemsolving methodologies to identify, prioritize, communicate, and resolve quality issues.
5. Support the development and execution of streamlined business systems that effectively identify and resolve quality issues.

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Quality Systems Duties and Responsibilities

• Build quality into all aspects of work by maintaining compliance with all applicable quality requirements.

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Qualifications

• Bachelors degree
• 35 years of relevant experience

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Supplier Quality Engineer



Role Purpose

Responsible for driving exceptional product quality for patients, enhancing customer value, ensuring regulatory compliance, and optimizing Cost of Quality.

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Responsibilities

1. Improve supplier quality performance through effective Part Quality Plan (PQP) implementation.

   • Communicate, clarify, and facilitate PQP submissions.
   • Conduct PQP reviews and approvals for purchased products.

2. Approve supplier selection through robust qualification processes, including supplier audits.

3. Ensure supplier compliance with the Quality Management System (QMS) and regulatory requirements.

4. Ensure development and execution of Corrective and Preventive Action (CAPA) plans in accordance with CAPA processes.

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Qualifications / Requirements

1. Bachelors degree in engineering or a technical discipline
   (or nontechnical degree with 5+ years experience in manufacturing, engineering, or quality assurance).
2. Minimum 3 years of experience in manufacturing, engineering design, quality assurance, or regulatory assurance.
3. Strong problemsolving and rootcause analysis skills with the ability to lead and influence change.

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Desired Characteristics

1. ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
2. Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
3. Supplier quality experience in the medical device industry.