Sr Ops Quality Eng

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.

About the Role

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, provides 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.

Responsibilities

• Provide input into regulatory filings as well as guidance for the various elements of the Quality System, including but not limited to: Annual Product Review, Process control, Change Control, Validation, Product complaints, Audits, Internal Audits, Supplier Quality, OOS, CAPA, and identification/recommendations for continuous improvement opportunities (internal/external).
• Apply 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.
• Provide site guidance and input to Regulatory Affairs to support all required regulatory filings.
• Manage the site Internal Audit program.
• Provide guidance and training to Quality Department personnel in all applicable Quality Systems.
• Lead compliance efforts for the site.
• Respond to customer inquiries.
• Serve as primary backup for Product Release.
• Prepare Annual Product Reviews and Management Reviews.
• Gauge monthly metrics.
• Provide direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices.
• Provide validation guidance and support for computer systems, production processes, and both production and laboratory equipment.
• Participate in and may lead continuous improvement activities (e.g., kaizen).
• Work within production teams to develop data trending models using appropriate statistical methods and deploy their use.
• Analyze trends related to various activities, identify root causes, and areas for improvement. Utilize output of trend analysis to initiate investigations and/or corrective/preventive action projects.
• Assess manufacturing and support processes to identify and implement quality-minded efficiencies and improvements.
• Lead or participate in risk analysis activities (FMEA) for changes to production or design processes. Use process mapping tools to define critical control points and recommend alternatives to reduce risk of defects.
• Oversee cross-functional teams for complaint investigation and resolution. Generate final complaint investigation reports.
• Lead investigation efforts and accurately document investigation plans, supporting data, and conclusions.
• Lead corrective and preventive action projects.
• Participate on extended core teams as a QA representative.
• Perform statistical analysis (Excel, Minitab, other statistical software).
• Develop sampling plans, as needed.
• Provide change management guidance and support.
• Provide internal/external audit support. May assume the Lead Auditor role.
• Serve as a subject matter expert for Regulatory and Customer audits.
• Conduct New Employee orientation.
• Provide 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.
• Perform other duties as assigned with or without accommodation.
• Participate in a certified 5S Workplace System to ensure good housekeeping and organization.
• Prioritize and plan workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
• Effectively train others in a positive manner.

Requirements

Education: B.S. degree in Engineering or Science or a related field.

Experience: Minimum of 5 years’ experience in QA/pharmaceutical manufacturing environment.

Skills

• 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.
• Strong computer skills/knowledge and statistical skills as applicable to Quality/Process Control.
• Knowledge of SPC, DOE, FMEA, Six Sigma, and Lean Manufacturing.
• 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

This position consults with all levels of plant personnel on issues and projects as required. It will also interact with personnel from other locations/positions within Mallinckrodt and 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 to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.