This job board retrieves part of its jobs from: Toronto Jobs | Emplois Montréal | IT Jobs Canada

Pursue your happiness! Your next job is here!

To post a job, login or create an account |  Post a Job

Quality Engineer Incoming Manager

PCI Pharma Services

This is a Full-time position in Philadelphia, PA posted September 1, 2021.

Job DescriptionSUMMARY:The Quality Engineer
– Incoming Manager is responsible for implementing testing equipment capabilitiesrelated to Medical Devices to be used during Incoming Quality Inspections.

The Quality Engineer-Incoming Manager will use the technical skills to implement/standardize Incoming Quality Inspections.The Quality Engineer
– Incoming Manager is responsible for aligning and supervising the members ofIncoming Quality Assurance (IQA) with the approved quality standards for incoming materials receivedfrom suppliers to ensure compliance with company drawings, specifications, and requirements as perCurrent Good Manufacturing Practices and Standard Operating Procedures.

Select, supervise, empower,coach, develop and retain a team of qualified IQA Inspectors while partnering with functional teams fromthe Business Units and Procurement.

The individual will also interact with the engineering, business unit,and production personnel to determine the cause and disposition of non-conforming material.ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAYBE ASSIGNED):Establish technical testing criteria for components related to medical devices.Subject matter expert on inspection equipmentImplementation of general and customer specific inspection criteria and testing.Coordinate the daily activities for IQA personnel.Select, supervise, empower, coach, develop and retain a team of qualified individuals througheffective employee development, performance management, succession planning andrecognition.Ensure the appropriate team structure is in place by performing workload analysis to manageheadcount and to ensure we deliver on customer and business commitments.Establish team and individual goals and objectives in alignment with department and siteobjectives.Manage the training and development of the team including onboarding of new employees.Manage Supplier Non-Conformance Program.Maintain IQA Metrics.Provide support for customer audits, visits and conference calls.Ability to foster an environment of continuous process improvementAttendance and the ability to inspire and lead a team are essential aspects of this jobDevelop and complete any relevant CAPA actions associated with the IQA areaAbility to understand and execute all aspects of the activities performed in Incoming QualityAssurance (IQA) related to the inspection, control, disposition, and release of incoming material.Management System and any applicable federal, state, or regulatory requirements.Record inspection results and take action on material disposition in accordance with approvedcompany processes and procedures.Accurately process all material transactions and ensure accuracy throughout the inspectionprocess.Create detailed documentation (pictures, PowerPoint presentations, etc.) of non-conformingmaterial in order to effectively communicate the issue to the appropriate supplier.HR
– Quality Engineer/Incoming Manager.doc Page 2 of 3Must be an effective team player who actively participates and cooperates with others to improvethe overall quality of our processes.Represents Quality on assigned project teams and leads those projects relevant to Quality toconclusion.Proactively follows up internally and with customers to secure missing documentation (i.e.Certificate of conformance, Certificate of Analysis, etc.) in order to ensure that all Qualityexpectations and parameters have been met and to expedite release of the material.Supports company strategic, departmental operational excellence and manufacturing regulatoryinitiatives.

Responsible for acting as the quality representative on capital projects.Actively participates in site inspection/audits by facilitating discussions with inspectors/auditors,fulfilling requests for information and presenting to inspectors on required topics.Provides training to new incoming personnel and ensures compliance with departmentalprocedures.Interaction with customers in order to answer Quality related questions and alignment withcusto in a professional and courteous manner.Performs other duties as assigned by Manager/Supervisor.SUPERVISORY RESPONSIBILITIES:Direct supervision of 5-10 IQA inspectors.

Carries out manager responsibilities in accordance with theemployees; staffing, planning, assigning, and directing work; appraising performance; rewarding anddisciplining employees; addressing complaints and resolving problems.RequirementsQUALIFICATIONS:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.The requirements listed below are representative of the knowledge, skill, and/or ability required.EDUCATION AND/OR EXPERIENCE:BA or BS degree and a minimum of 3+ years of technical quality and manufacturing experience ina pharmaceutical or biotech environment.Possesses excellent organizational, time management and multi-tasking skills in order to meetcommitments and deadlines.Knowledge of basic test instrumentation such as scales, balances, micrometers, calipers, rulers,etc.Strong problem solving skills and detailed oriented.Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, andProject, and a working knowledge of GMPs.Basic understanding of cGMP requirements and AQL sampling plansLegible HandwritingAny Lean Six Sigma or process improvement training is a plusLANGUAGE SKILLS:Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members ofthe business community.

Ability to effectively present information to management, customers, andregulatory inspectors.

Must have strong interpersonal and excellent communication skills.COMPUTER SKILLS:HR
– Quality Engineer/Incoming Manager.doc Page 3 of 3The candidate must be able to perform more complex computer tasks and has knowledge of variouscomputer programs and technical software.

(e.g., MS Office) and technical software (e.g., TrackWise,others).Ability to create, use and interpret scientific tables, charts, and graphs.REASONING ABILITY:Ability to solve practical problems and deal with a variety of concrete variables in situations where onlylimited standardization exists.

Ability to interpret a variety of instructions furnished in written, oral,diagram, or schedule form.PHYSICAL DEMANDS:Ability to sit or stand for long periods of time.

Ability to move safely in a shipping/receivingenvironment.Must be able to lift up to 25 lbs.The physical demands described here are representative of those that must be met by anemployee to successfully perform the essential functions of this job.

Must be physically capableto perform the above duties with or without reasonable accommodations which may be made toenable individuals with disabilities to perform the essential functions.WORK ENVIRONMENT:The work environment characteristics described here are representative of those an employeeencounters while performing the essential functions of this job.The noise level in the work environment is usually moderate.Equal Opportunity Employer/Vet/Disabled