Sr. Quality Engineer

Avalign Technologies; Warsaw (IN); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Healthcare benefits

Tuition reimbursement

401(k) match

Paid vacation

Job summary

Avalign Technologies in Indiana is seeking a Quality Engineer to drive quality improvements across manufacturing and supplier processes. You will develop inspection plans, support validation activities for NPI transfers, and lead CAPA investigations to sustain product quality throughout the lifecycle.

The role requires a BS in engineering and at least 5 years of manufacturing experience, with knowledge of ISO 13485 and 21 CFR 820.

Qualifications

• BS in engineering science and at least 5 years of manufacturing experience.
• Understanding of ISO 13485 and 21 CFR 820 regulatory requirements.
• Ability to read blueprints, GD&T, and inspection methods.

Responsibilities

• Provide quality leadership in manufacturing inspection plan development.
• Lead validation planning for NPI transfer activities and assist teams in determining validation needs.
• Support CAPA investigations and drive continuous improvement across processes.

Skills

Quality leadership

Validation planning

CAPA investigations

Supplier management

Quality system

Risk management

Gage R&R

Statistical analysis

Process improvement

Education

BS in engineering science

Job description

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.

The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met.

What You’ll Do:

• Provides quality leadership in manufacturing inspection plan development.
• Provides leadership to engineering and manufacturing functions for validation planning and NPI transfer activities. Assists teams in determining validation needs and requirements.
• Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
• Primary quality representative for site supplier management and resolution of supplier nonconformances
• Support internal and external audits to maintain regulatory, customer and Avalign compliance.
• Manages Non-Conforming Material Reports system and dispositions all non-conforming product.
• Enhances and drives product risk management activities. Ensures identified activities and mitigations are executed.
• Participates in technical discussions and risk-based decision making.
• Identifies opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement.
• Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Recommends test methods and statistical process control procedures for achieving required levels of product reliability.
• Conducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria, including capability studies and Gage R&R studies.
• Acts as main Quality Engineering contact for assigned customers and projects.
• May supervise quality technicians and/or inspectors as needed at the manufacturing facility.
• Serves as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.
• Supports operations and engineering teams to ensure the Material Review Board process is followed.
• Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.
• Submit documentation to customers for new product launches and legacy product documentation requests.

Competencies/Essential Functions:

To perform the job successfully, an individual should demonstrate the following:

• Leads assigned team in the development of quality related processes & initiatives.
• Monitor complaint trends and data in order to elevate emerging issues appropriately.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements

What You’ll Need:

• Candidates should have a BS in an engineering science plus at least 5 years of manufacturing experience, or an equivalent combination of education and experience.
• New production introduction/process development experience in a manufacturing environment highly preferred.
• An understanding of quality standards (ISO 13485) & regulatory requirements (21CFR820).
• Ability to read and interpret blueprints as well as have a Knowledge of GD&T, and Inspection methods.
• Ability to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.

What You Won’t Do:

• Feel stuck – we offer great opportunities to advance and learn
• Get bored – we make a high variety of products, so no day is the same
• Feel like a number – we’re a close-knit bunch and always have each other’s backs

Who You Are:

• A self-starter who thrives in a fast-paced environment
• A quick learner who is always ready to gain depth of knowledge in manufacturing processes
• A reliable individual who knows the importance of showing up when it counts
• Someone who accept assignments with an open, cooperative, positive and team-oriented approach
• Someone who is able to plan and execute plans across teams
• An effective communicator, both written and verbal

What You’ll Enjoy:

• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Working for a thriving, performance-based company that values promoting from within and career advancement
• Temperature controlled environment
• Community involvement investing and giving back to the community
• Additional free resources such as travel assistance, EAP, etc.

Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.