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Solesis · 3 months ago

Manager, Quality Engineering

Quakertown, Pennsylvania, United States

Full-time

Onsite

Mid, Senior Level

5+ years exp

Solesis is a company focused on quality engineering, and they are seeking a Quality Engineering Manager. This role is responsible for developing, applying, and maintaining manufacturing and quality management systems to ensure compliance with internal procedures and regulatory standards.

Health CareManufacturing

Responsibilities

Performs and documents timely Corrective and Preventive Actions (CAPA) investigations

Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation

Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines

Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regard to non-conformances, supplier changes, etc

Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols)

Performs statistical data analysis utilizing statistical software (Minitab and Excel)

Develops and implements statistical methods and designs experiments to support process control and process/product improvement

Performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes

Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), etc.)

Supports development and implementation of methods for sampling, inspection, testing and evaluation of products

Interfaces with customers to provide technical support for our products/complaints/change control

Reviews/approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), RQP, Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.)

Supports customer and/or third-party audits as required

May be trained as an auditor and perform quality audits

Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations

Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement

Completes performance appraisals and reviews with employees; recommends salary increases to management and HR

Provides input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements

Manages other Quality Engineers, to be able to participate in their development and performance reviews

Supports Strategic accounts as assigned and as needed

Qualification

Quality EngineeringRegulatory Standards KnowledgeStatistical AnalysisProject ManagementRisk ManagementProcess ImprovementTeam LeadershipCustomer ServiceSupervisory SkillsMS Office SuiteMinitabCommunication SkillsProblem Solving

Required

Bachelor's degree in one or more of the following - Life sciences Engineering, Engineering, Quality, Life sciences

5-7 years- including co-op experience

Minimum 3–5 years of direct managerial or supervisory experience, including hiring, coaching, performance management, and team development; proven ability to lead cross-functional teams and drive departmental goals

Experience in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering or Manufacturing Engineering

Knowledge of applicable regulatory standards, specifically ISO 13485 or possess the ability to understand and enforce the practices

Able to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community

Strong problem solving and analytical skills, with concentration on risk analysis

Demonstrated project organizational skills required

Strong written and verbal communication skills

Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables

Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities

Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab)

Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management, and process control

Excellent customer service focus and professionalism

Strong Supervisory skills