Sr Quality Engineer

Innovize & Xcel Scientific; Saint Paul (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Innovize & Xcel Scientific, located in Saint Paul, MN, is seeking a Quality Engineer to develop and maintain methodologies that meet customer requirements. This role ensures compliance with U.S. and international regulations regarding quality standards.

The ideal candidate will have over 8 years in medical manufacturing, experience in GMP facilities, and knowledge of quality system standards including ISO, FDA, and MDD. The position is a full-time role focused on enhancing product quality and regulatory adherence.

Qualifications

• Minimum 8 years experience in a medical manufacturing quality environment.
• Direct experience in a Quality role supporting operations in a manufacturing GMP facility.
• Strong background in international Quality System standards.

Responsibilities

• Works to implement effective controls for product manufacturability.
• Leads testing and validation of new customer product designs.
• Creates and maintains Regulatory Affairs product files.

Skills

Quality Engineering

Risk Management

Process Improvement

Root Cause Analysis

Regulatory Compliance

Education

Bachelor's Degree

Quality Engineering Certification

Tools

Microsoft Office

MiniTab

Job description

Job Details

Location: Saint Paul, MN 55127
Position Type: Full Time
Salary Range: $90,000.00 - $120,000.00 Salary/year
Job Shift: Days
Job Category: Quality

Summary

Develops, establishes and maintains Quality Engineering methodologies, systems, and practices that meet Innovize customer requirements. Provides focused Quality Engineering support of manufacturing and test process development for new products to ensure the delivery of the highest quality product to the customer. This position develops and maintains current knowledge of applicable U.S. and international regulations, standards and guidance and ensures that products are manufactured in compliance those requirements and customer expectations. This position will drive successful development, deployment and maintenance of business processes, tools and training.

Duties/Responsibilities

• Works within the Operations Team to identify and implement effective controls to support the development, qualification, and manufacturability of products to meet or exceed internal and external requirements.
• Lead in the testing and validation of new customer product designs to meet or exceed internal and external requirements.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Maintain a thorough understanding of regulations and guidelines (FDA, ISO, MDD etc). Assess effectiveness of systems with respect to all relevant regulations and requirements.
• Prepare regulatory plans and compliance requirements including risk analysis. Provide on‑going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
• Create and maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Identify, design, and implement process and system improvements.
• Serve as a technical subject matter expert (SME) on quality systems, processes, and issues in support of team functions.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Manage competing priorities and maintain accountability for deliverables affecting team and organizational objectives.
• Set personal performance goals and collaborate with management to establish organizational objectives.

Accountabilities

• Accountable to meet safety goal.
• Accountable to achieve product and service quality goal.
• Accountable for equipment installation and operational qualification.
• Accountable for closing assigned customer corrective actions within twelve business days.
• Accountable for projects and project revenue.
• Accountable to achieve goal for profit contribution dollars.
• Accountable for passing work habits verification with no findings.
• Accountable for meeting or exceeding utilization requirements of the Recognition Program.
• Accountable for learning and development.

Qualifications / Training / Education / Experience

• Minimum 8 years experience in a medical manufacturing quality environment.
• 4 year Bachelor’s Degree, Quality Engineering certification preferred.
• Direct experience in a Quality role supporting operations in a manufacturing GMP facility.
• Experience applying process improvement tools and methodologies such as DMAIC, LEAN/Six Sigma.
• Strong background in international Quality System standards and medical product regulatory requirements such as ISO, FDA, MDD, etc.
• Demonstrated practical risk management skills, including facilitation using risk management tools (e.g. FMEA, etc.).
• Strong root cause analysis and problem solving skills at a tactical level.
• Sound knowledge of validation principles.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
• Ability to communicate clearly and professionally both in writing and verbally.
• Proficient PC skills to include Microsoft Office (Excel, Word, Outlook). Experience with MiniTab or similar is preferred.

Competencies / Talents / Personal Attributes

• A thorough understanding of medical manufacturing, its environment and requirements.
• Collaborative Leadership – ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity, able to create order from chaos.
• Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted – delivers on promises, goals and expectations. Makes decisions based on data and facts and resolves problems rapidly.
• Communication – Ability to communicate effectively at all levels of the organization, present complex and/or new ideas with clarity and simplicity. Can speak, understand and write English.
• Planning/Organization – Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amounts of information.
• Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data‑driven root causes. Innovative and effective in solution development, risk mitigation and execution. Ability to integrate Quality Systems to assure seamless flow of information and improve data utilization and interpretation across multiple teams.
• Customer Focused – Partners with customers, ability to look ahead to predict future customer needs. Proactively manage expectations.

Evidence of Success

• Can show historical evidence of successfully overseeing the manufacturing processes for FDA regulated products that have been validated.
• Can show historical evidence of success that Device History Records were accurate and that products were manufactured according to the customer’s Device Master Record.