Senior supplier quality engineer job description

Effective Date: 7/1/2022

Location: Alachua, FL

While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).

SUMMARY:

RTI Surgical is global, industry-leading private label OEM with expertise in allograft, xenograft and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.

As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic and reconstructive surgery, urology/urogynecology and trauma.

RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values:

• We are accountable to each other by trusting each other’s judgement and hold each other responsible for results.

• We find joy by striving to create a working environment that people enjoy.

• We fully engage by focusing our hearts and minds on our customers, patients, and each other.

• We adapt to change by working collaboratively to be flexible to the changing needs of our business.

RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in the Greenville, N.C. and Germany.

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and have supported the transformation of the company to its next level of potential.

POSITION SUMMARY:

This position is responsible for supporting the quality team with task responsibility. This involves modeling and detailing inspection prints, contributing individually and within cross-functional teams, and general project support. This engineer is a self-starter, have a hands-on approach in performing their work duties, and be able to work independently. This position will help RTI Surgical maximize the number of patients served while maintaining a high level of quality and safety

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The Opportunity

As the company continues to grow we are seeking a Senior Quality and Supplier Quality Engineer. The Senior Quality and Supplier Quality Engineer will provide quality engineering support at the Rochester site. The candidate will develop and maintain effective working relationships with suppliers and manage supplier onboarding activities, supplier-related changes, and provide supplier quality oversight via supplier monitoring activities. The candidate will work to resolve company and supplier nonconformances by ensuring adequate RCIs are conducted and effective CAPAs are implemented. The candidate will utilize statistical tools, sampling methodologies, and ensure supplier activities are conducted in compliance with company policies and procedures. The candidate will utilize key Quality Engineering principles, tools, and practices to develop and optimize process controls and quality system processes and identify opportunities to improve quality and cost that are aligned with the overall business goals and Ortho's Quality Policy. The candidate will also utilize risk management and process excellence tools to identify risk factors in the quality system and lead activities to implement risk mitigation plans.
This position is in Rochester, New York.

The Responsibilities
Support manufacturing and staff in addressing supplier-related quality events for raw materials and bulk fluids by working with suppliers to drive the identification of root cause and implementation of corrections and corrective actions while adhering to quality metric timelines. Work with engineering, product support, and quality to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in the development of and changes to inspection methods and sampling plans for materials and components. Ensure adequate supplier control plans are implemented, documented, and maintained. Develop quality agreements, oversee supplier monitoring activities, and support supplier changes. Partner with operations to evaluate and address quality events including nonconformances, product dispositions, root cause investigations, and CAPA. Properly assess risk of quality events and ensure that appropriate and timely mitigations (short and long-term) are implemented. Analyze and monitor key quality metrics and develop action plans to address unfavorable trends. Support and promote continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce variation and improve product quality. Support and participate in inspection readiness activities by applying working knowledge of ISO13485 and 21CFR Part 820 regulations for supplier and manufacturing audits. Support and execute supplier audits. Provide coaching, training, and technical guidance to business partners in aspects of the company quality system requirements as they pertain to manufacturing quality and supplier quality.

The Individual
B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline. 5-7 years of experience in Quality in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer).Advanced Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.

EOE/AA Disability/Veteran

Our people create our best Plexus.

WHO WE ARE

We're a global team of over 19,000 engineering, manufacturing, supply chain and aftermarket service experts who partner with customers to bring their products to life through inspired innovation and world-class customer service.

We are passionate about innovating, creating and delivering products that change people's lives. From surgical devices and health monitors to warehouse robotics and space products, we partner with our customers to help create the products that build a better world.

Whether you're looking to start, make a change or advance your career, find your path at Plexus Corp. and leave your mark on the world.

WHY WE LOVE IT

Engaging and challenging projects that fulfill and develop you. People that inspire and empower you to realize your full potential. Leadership and development programs to support your career goals. A workplace centered on inclusion and collaboration. At Plexus, we're at our best when opportunities are met with passion, open communication and teamwork.

HOW YOU WILL DO IT

Purpose Statement: This position is responsible for updating and maintaining supplier controls in regards to quality and compliance for incoming raw materials and services.

Key Job Accountabilities:
Strategy - Tactical execution of global Supplier Quality strategic initiatives to develop key supplier capability for strategic growth and supplier processes to enable flawless execution.Part Qualification - Manage the execution of part qualification activities at the Site level to ensure Q-Code and inspection plan requirements are verified and documented. Ensure part qualification/verification requirements are assigned to Customer BOM at the part number level (non-full value stream projects).Supplier Performance Monitoring - Monitor supplier quality performance metrics, inclusive of product yield and scar response rates. Provide necessary supplier feedback to drive supplier performance improvement. Produce supplier metrics to support customer and supplier business reviews.Material Issues - Lead problem part resolution through all phases of operations, including containment, segregation, NCM review, and trend analysis activities relative to supplied non-conforming parts. Responsible for leading required supplier corrective action activities resulting from non-conforming parts.Supplier Quality Management System -Tactical execution of supplier quality systems and tools, inclusive of verification of purchased product processes, NCM, SCAR, supplier performance data collection and flow-down requirements at the site level.

Additional Accountabilities:
Conduct supplier audits to defined assessment criteria to ensure supplier capabilities meet current and future strategic growth requirements including regulatory, business and customer Quality Management System requirements and applicable process/product qualification and controls.Responsible for leading required supplier corrective action activities resulting from non-conforming parts and supplier audits. Supports and leads supplier process development activities as required e.g. process validation capability.Additional duties as assigned.

Education/Experience Qualifications:
A minimum of a(n) Bachelor's degree is required; a(n) Bachelors' degree in Engineering or similar field is preferred.5 years of related experience is required; 7 years of related experience is preferred.Experience of working in a Plexus manufacturing environment is preferred.

An equivalent combination of education and experience sufficient to successfully perform the key job accountabilities may be considered.
Other Qualifications:
ASQ Certification preferred (CQE, CQA, CMQOE) Broad understanding of materials, manufacturing technologies and processes

Physical Requirements:
None

Work Environment:
The work setting should consist of a manufacturing environment with suitable lighting, comfortable temperatures, and a moderate noise level.

This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform.
Some offers of employment are contingent upon successfully passing a drug screen and upon completion of a confidentiality agreement.Our Values and How We Lead behaviors guide our processes. Plexus does not make employment decisions based on race, color, religion, national origin, sexual orientation, gender identity, disability, or veteran status. We are proud to be an Equal Opportunity Employer (EOE) and encourage all to apply today!Globally, our policy is to recruit people from wide and diverse backgrounds. However, our company does not typically undertake sponsorship, including for H-1B, TN, and other nonimmigrant visas. Additionally, certain positions require access to controlled goods and technologies subject to the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Applicants for these positions may need to be “U.S. persons.” “U.S. persons” are generally defined as U.S. citizens, nationals, lawful permanent residents (or, green card holders), individuals granted asylum, and individuals admitted as refugees.