Senior Operations Quality Engineer
Mallinckrodt
Raleigh, North Carolina
senior
operations
engineer
engineer
production
manufacturing
management
personnel
operations
quality systems
regulatory
supplier quality
tools
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December 4, 2022
Mallinckrodt
Raleigh, North Carolina
FULL_TIME
Job Title
Senior Operations Quality Engineer
Requisition
JR000012546 Senior Operations Quality Engineer (Open)
Location
Raleigh, NC (Pharma) - USA033
Additional Locations
Job Description
SUMMARY OF POSITION:
The Sr. Quality Engineer has responsibility for interpreting and applying the applicable regulations and Quality Systems, and developing and implementing standard operating procedures (SOPs) and policies. 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 Sr. Quality Engineer will provide statistical and process support to assist with continuous improvement activities.
ESSENTIAL FUNCTIONS:
The role provides input into regulatory filings as well as guidance 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 Sr. 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 a lead for certain Quality Systems ownership for day to day activities and monthly metrics and trending.
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.
Serves as a subject matter expert for Regulatory and Customer audits.
Provides 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.
Supports validation activities. Provides validation guidance and support for computer systems, production processes, and both production and laboratory equipment.
Provides change management guidance and support.
Provides internal / external audit support. May assume the Lead Auditor role.
Provides guidance and training to Quality Department personnel in certain applicable Quality Systems.
Provides direction and leadership for 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).
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.
Oversees cross functional teams for complaint investigation and resolution. Generates final complaint investigation reports.
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.
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 others in a positive manner.
MINIMUM REQUIREMENTS:
Education:
B.S. degree in Engineering or Science or a related field
Experience:
Minimum of 5 years’ experience in QA/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.
Direct interactions with regulatory inspections.
Strong technical, oral, and written communication skills.
Able to speak, read, and write the English language.
Knowledge of Six Sigma Tools or certification.
Good project management, problem solving, team building, and negotiation skills. Good facilitation, presentation, and prioritization skills.
Ability to manage multiple projects.
Must have strong computer skills/knowledge and statistical skills as applicable to Quality/Process Control.
Knowledge of SPC, DOE, FMEA, Six Sigma and Lean Manufacturing.
Individual must be self-motivated, able to achieve results with minimum supervision.
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
CQE certification preferred, CQA certification preferred
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.
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