Lead Operations Quality Engineer

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

SUMMARY OF POSITION:

The Lead Operations Quality Engineer has overall responsibility for the investigations, corrective actions, change controls and compliance activities that occur in the Quality Engineering group. This role provides direction and assignments to other Quality Engineers in the group for open assignments and priorities for product release. Interprets and apply current regulations and guidance to ensure site policies and procedures provide a compliant framework for Quality Operations. Interface with Process Engineers and Production Management to resolve exceptions and change controls. The Lead Quality Engineer will provide statistical and process support to assist with continuous improvement activities.

Job Description

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: Validation, Deviations (Exceptions), Risk Management, Product complaints, Internal Audits, OOS, CAPA, Annual Product Review, Process control, Change Control, and identification/ recommendations for continuous improvement opportunities (internal/external). The Lead 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 SME for validation activities. Provides validation guidance and support for computer systems, production processes, and both production and laboratory equipment.
• Provides leadership and guidance to technical functions on risk management principles and techniques
• 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.
• 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. 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.
• 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.

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:

Bachelor’s degree in a scientific discipline or technical field related to pharmaceutical manufacturing or equivalent combination of education, experience, and competencies.

Experience:

Minimum of 10 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

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, CQA certification

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.