Operations Quality Engineer II

Job Title

Operations Quality Engineer II

Requisition

JR000014661 Operations Quality Engineer II (Open)

Location

Raleigh, NC

Additional Locations

Job Description Summary

The Quality Engineer has responsibility for interpreting and applying the applicable regulations and Quality Systems. In a cGMP manufacturing setting, provide Process / Quality Engineering support to all areas of the facility to ensure delivery of the highest quality product to the customer. The Quality Engineer will provide statistical and process support to assist with continuous improvement activities.

Job Description

ESSENTIAL FUNCTIONS:

The role provides support for the various elements of the Quality System, including but not limited to the following: Deviations (Exceptions), Supplier Quality, Product complaints, Internal Audits, OOS, CAPA, Annual Product Review, Process control, Change Control, Validation, and identification/ recommendations for continuous improvement opportunities (internal/external). The Quality Engineer applies the appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity.

Additional functional requirements:

• Acts as lead for Quality Systems ownership for day-to-day activities, support of the Quality function (QA) daily, and monthly metrics and trending. 
• Supports compliance efforts for the site.
• Supports Quality system improvements and for benchmarking of other sites to establish and implement best practices.
• Participates in continuous improvement activities as required. May lead continuous improvement activities (e.g. kaizen).
• Works within production teams, develop data trending models using appropriate statistical methods and deploy use of them.
• Analyzes trends related to various activities and identify root causes and areas for improvement. Utilizes output of trend analysis to initiate investigations and or corrective/preventive action projects.
• Assesses manufacturing and support processes to identify and implement quality minded efficiencies and improvements.
• Leads or participates in risk analysis activities (FMEA) for changes to production or design processes. Uses process mapping tools to define critical control points and recommend alternatives to reduce risk of defects.
• Supports product complaint efforts including root cause analysis and CAPA
• Leads investigation efforts and accurately document investigation plans, supporting data, and conclusions.
• Leads corrective and preventive action projects.
• Participates on extended core teams as a QA representative.
• Statistical analysis (Excel, Mini-tab, other statistical software).
• Develops sampling plans, as needed.
• Provides change management guidance and support.
• Provides internal and external audit support as an SME.
• Assists supplier quality oversight, including technical support for supplier selection and supplier quality evaluations as well as the development and management of supplier corrective action plans. Work closely with suppliers to ensure quality expectations and strengthen supplier relationships. 

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

Other duties as assigned with or without accommodation.

• Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
• Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
• Effectively trains, coaches, and corrects, others in a positive manner.

MINIMUM REQUIREMENTS:

Education:

B.S. degree in Engineering is preferred, other degrees may be considered with relevant experience. 

Experience:

1-5 years’ experience in QA or a pharmaceutical manufacturing environment

Preferred Skills/Qualifications:

Other Skills/Competencies:

Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP.

Experience in root cause analysis and risk analysis

Good project management, problem solving, team building, and negotiation skills. 

Strong technical, oral, and written communication skills.

Able to speak, read, and write the English language.

Knowledge of Six Sigma Tools

Ability to plan and execute tasks on multiple projects simultaneously

Must strive for continuous improvements in all work activities

Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing

Command Skills, Action Oriented, Conflict Management, Customer Focus, Timely Decision Making, Functional / Technical Skills, Presentation Skills, Problem Solving, Priority Setting, Dealing with Ambiguity, Written Communication

RELATIONSHIP WITH OTHERS/ SCOPE:

• This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt.
• This position interacts with personnel outside the company on a customer and supplier level.
• This position requires self-motivation and daily execution of tasks with limited supervision interaction.

WORKING CONDITIONS:

• Generally normal office and meeting room conditions, but must complete some routine assignments in plant and non-air conditioned production environment.
• Exposure to fugitive emissions of chemicals typical for chemical operations.
• Position may require some travel.
• Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.