Quality Systems Lead Jobs

Excellent Time Management, Prioritization and Organizational skills

Identification and Management of Microbiological Organisms and Systems Experience in Lean Manufacturing

Minimum 3 years of experience as a quality supervisor, quality lead/manager, quality engineer.

Knowledge of relevant Food Safety and Regulatory requirements

Ensures Food Safety the of the assigned production line(s) by implementing the relevant legal & Corporate Requirements (HACCP, GMP, etc.).

Identify, participate, facilitate or support Operations for Quality related RCA’s Manage Corrective and Preventive Action Program for assigned production line(s).

Manage the selection, configuration, validation, deployment, operation and maintenance of the electronic quality management system and related infrastructure

Bachelor's degree in life sciences, engineering, or related field. Equivalent combination of education and applicable job experience may be considered.

Familiar with ICH Q9 and ability to apply quality risk management principles

10+ years of relevant Quality experience including implementing and managing GxP quality systems in the pharmaceutical/biotech industry

Experience working in a virtual work environment at a small or mid-sized company is strongly preferred

Breadth of knowledge across various functional disciplines including Quality Systems, Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

Experience setting up and leading a Quality Management System

AS9100D Lead Auditor certification and advance knowledge in AS9100D requirements required

5-8 years experience sustaining a Quality Management system in aerospace/manufacturing environment

Conduct quarterly/semi quarterly management review and follow up with action plan

Administer QMS policies, document management system (DMS), document control process relative to the scope of Insitu QMS

Support quality manager sustaining AS9100D registration

Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements

5+ years’ experience with U.S. Navy or USMC aviation logistics, maintenance and acquisition practices

Experience with 4790.2 Naval Aviation Maintenance Program (NAMP)

5+ years’ experience maintaining P-8A Aircraft Logs, and Records Books IAW 4790.2

5+ years of experience with P-8A, QAS, Full Systems QAR, CDQAR or CDI

Experience with MPA or CNAL audits

Conduct employee training on applicable Quality SOPs and regulatory requirements under the guidance of Quality Management

Conduct supplier assessments and routine/qualification audits in accordance to Supplier Management program.

Must have excellent skills in organization, negotiation, problem solving and time-management.

Participate in the initiation, documentation, and management of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls).

Report to management all quality issues, trends and/or losses

Other duties as assigned or identified by Quality Management.

Experience or working knowledge of Quality Management Systems and related global standards

Proven project management skills to efficiently balance workload and competing priorities

Lead external third-party audits to sustain global certifications.

Define and specify activities, processes, and standards to fulfill the quality system requirements for services and products.

Strong analytical, problem-solving, and decision-making skills

Problem-solving and root cause analysis experience utilizing quality tools, such as DMAIC, FTA, 8D, etc.

Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.

Work closely with site senior management to provide strategic direction and development of the organization’s quality strategies and tactics.

Serve as the site’s Management Representative and lead the organization’s Management Review process.

Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC).

Ensure compliance with appropriate domestic regulatory and international standards and requirements.

Manage the complaint handling processes to insure customer responsiveness and product and process improvements.

Software Knowledge: Quality Management Systems and related tools including APQP, PPAP, control planning, and FMEA

Education: High School Diploma or GED required

Experience: 3 or more years of experience required, experience in a manufacturing environment preferred

Instruct, correct, and train employees in the proper use of inspection equipment and the performance of their work.

Establish a planned quality audit system in compliance with third party auditors.

Develop process audits and frequencies for torques and welds on safety sensitive joints.

Experience with regulatory inspections as well as a strong understanding of change control, deviation, CAPA management and Quality Risk Management

Manage various QPS (i.e. Deviation, CAPA, Change Control, Risk Management, Complaints), including implementing systems and processes to support each program

Lead quality management systems (QMS) implementation

Oversee the Laboratory equipment Maintenance/Calibration/Qualification program

Minimum of 7+ years of experience in the pharmaceutical, biopharmaceutical, and/or medical device industry

Strong knowledge of FDA regulations, quality systems and guidance documents

Coordinate and lead streamlined management review meetings, customer complaint reviews, and other quality meetings.

Tailor quality solutions to the chemical, food, personal care, pharmaceutical, etc. requirements for the area, product, and personnel.

Working knowledge of ISO 9000.

Prefer knowledge of FSCC 22000, Food Safety, Food Defense, HACCP, and ICH Q7.

Good verbal communication skills and strong ability to write technical reports or documents for internal and external use.

Assist all departments to ensure quality documents are maintained, and quality actions are completed in a timely fashion.

Maintains awareness and complies with hazardous waste management and other environmental management requirements in the workplace by attending scheduled training sessions.

Performs record keeping duties as required under the direction of management.

Communicates with the emergency coordinator (EC) or Environmental Focal Point/Environmental Manager (EFP/EM) regarding environmental management activities.

Performs such individual assignments as management may direct.

High School Diploma or education equivalent required.

Job-related experience for 3 years minimum.

2-4 years min of related work experience or an equivalent combination of formal education, on-the-job training, and/or work experience

Working knowledge of MS Office Suite

Knowledge of lean principles (preferred)

Team with Global co-workers to ensure that new product requests are completed in a timely fashion.

Review and audit system data to ensure product profiles are accurately maintained and update as needed.

Review and action requests to re-profile product and escalated new part requests.

Time management and ability to handle multiple tasks on time

Responsible for management of the record retention system

Minimum of 3 years’ experience in a Quality Assurance role within an FDA regulated manufacturing or distribution facility required

Experience in database applications (e.g. Excel, Access) required

Experience in quality system databases (Agile, web based applications) preferred

Experience conducting root cause investigations and developing CAPA plans required

Experience with risk management tools

Support Quality Management System through audits, inspections of materials, processes, equipment, corrective actions, deviations, risk analysis, and implementation of quality measures

Management of quality metrics/KPIs and their review through trend analysis and interpretation

Understanding and application of the ISO 9001 Quality Management System

Aid in ensuring compliance to Quality Systems regulations including ISO 9001:2015 Standard and corporate requirements

1 + year of work experience in Quality Assurance

Responsible for investigation management of critical, major, and minor investigations related to GxP operations.

Supports management review process through development, generation, and review of quality system metrics and trending, and escalate issues as required.

Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

Bachelors Degree and 10+ years of experience required OR

Masters Degree and 8+ years of experience required OR

Provide status reports on project progress to Project Management staff. Attend Project meetings.

Manage Quality issues with Inspectors and site leads.

Perform other responsibilities associated with this position as may be appropriate.

Requires 8 to 15 plus years’ experience in communication construction and engineering, installation, and trouble shooting.

Able to read and understand specifications, blueprints, and understand requirements.

Requires proficient PC skills including software such as Microsoft Word, Excel, and PowerPoint.

Facilitate and maintenance of Management Review Committee (MRC)

Bachelor s degree; and 4 years experience in Quality Systems and/or Process Auditing; or equivalent combination of education and experience.

To provide support for the Quality Management Systems, company-wide.

Perform Audits per ISO Guidelines, and Regulatory Requirements. (all shifts)

Sound communication, organizational and analytical skills with the ability to plan work and conduct effective meetings.

Maintenance and Administration of the ISO Document Control and compliance system.

Basic Qualifications (Required Skills and Experience)

Serve as the BGS Philadelphia Deputy Quality Management Representative

3+ years of experience working with regulatory agencies (DCMA, FAA, and/or Military)

5+ years of experience in the application of AS9100

+5 years aerospace quality experience

This position offers relocation based on candidate eligibility.

Experienced in the areas of Interior Lighting & overall vehicle lit harmony for conformance to illumination requirements is preferred

Ability to create and deliver effective presentations to Management, with Managerial Courage.

Knowledge of product engineering, manufacturing processes and new vehicle launch process

Computer software skills – especially with Excel and PowerPoint

Self-motivated, Pro-Active, Decision Maker with ability to simultaneously manage multiple programs

Lead the evaluation of interior illuminated parts for assigned programs

Strong project management, communication skills and the ability to multi-task.

Desired experience with software Quality System management tools

Experience in maintaining or implementing international standards (i.e., ISO9001) and FDA regulations. Leadership, communication, and presentation skills.

Experience in regulated industries and strong knowledge of Quality Systems practices and related regulations.

Collaborate with all functions (formulations, quality assurance, quality lab, production, supply change) become knowledgeable in all areas in premix.

Interaction with staff of varied experience and expertise across the company network.