Endo · 12 hours ago
Sr. Operations Quality Engineer
Raleigh, NC (Pharma) - USA033
Full-time
Onsite
Senior Level
5+ years expMallinckrodt Enterprises LLC is a healthcare company committed to improving lives through quality and safety. The Sr. Quality Engineer is responsible for ensuring compliance with regulations and Quality Systems while providing Process/Quality Engineering support in a cGMP manufacturing setting to deliver high-quality products.
Pharmaceuticals
Responsibilities
Provides input into regulatory filings as well as guidance for the various elements of the Quality System, including but not limited to the following: Validation, Deviations (Exceptions), Supplier Quality, Product complaints, Internal Audits, OOS, CAPA, Annual Product Review, Process control, Change Control, and identification/ recommendations for continuous improvement opportunities (internal/external)
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
Acts as SME for validation activities. Provides validation guidance and support for computer systems, production processes, and both production and laboratory equipment
Acts as lead for Quality Systems ownership for day to day activities and monthly metrics and trending
Provides guidance and training to Quality Department personnel in all applicable Quality Systems
Leads compliance efforts for the site
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)
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
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
Provides change management guidance and support
Provides internal / external audit support. May assume the Lead Auditor role
Serves as a subject matter expert for Regulatory and Customer audits
Conduct New Employee orientation
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
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
Qualification
Required
B.S. degree in Engineering or Science or a related field
Minimum of 5 years' experience in QA/pharmaceutical manufacturing environment
Strong technical, oral, and written communication skills
Able to speak, read, and write the English language
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
Preferred
Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP
Direct interactions with regulatory inspections
Knowledge of Six Sigma Tools or certification
CQE certification preferred, CQA certification preferred
Company
Endo
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
Founded in 1997Malvern, , US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Blaise Coleman
President and Chief Executive Officer
Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
Recent News
2025-09-23
2025-09-22
Company data provided by crunchbase