Senior Quality Systems Specialist Jobs

Background in Medical Device industry is highly desired.Pharmaceutical experience only would be acceptable.

Technical Writing (author SOPs & Work Instructions)

Medical Device (pharmaceutical is fine)

This person will assume a hands-on role and report into the IT Business Partner.

This Candidate must have a background in the following:

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.

Knowledge of regulatory change management including common board of health reportability requirements

Knowledge of DMAIC process, lean principles and quality risk management.

Responsible for front line decision making for site change records and regulatory change management

Provide support to other site quality systems including investigations/CAPAs, document management, training, and product complaints as required

Requires no supervision for routine assignments and recognizes when management involvement is necessary

A team player with excellent interpersonal, organizational, and communications skills (verbal and written)

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.

Requires working knowledge of the principles, practices, and tools related to Total Quality Management.

Maintain current knowledge of quality and tissue banking best practices and evolving industry trends and requirements.

Requires interpersonal ability to effectively interact with management and staff.

Requires excellent organizational skills, ability to manage competing priorities, and the ability to maintain a high-level of accuracy.

Supports the Quality Assurance team in preparing responses for qualification surveys of LifeLink Tissue Bank.

Requires experience in participating in supporting complex quality systems and quality audits.

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

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.

Quality Assurance, Internal Auditing, Quality Compliance Management or related experience

Support compliance gap management activities e.g. compliance risk management- Identifies risks to the division and resolutions to address compliance gaps.

Help management of near miss program

Provides Quality System Body of Knowledge expertise and support to organization.

Lead in the implementation of assurances, process controls, and CAPA related systems designed to meet or exceed internal and external requirements.

B.S. in Engineering / Business / Operations discipline or equivalent, plus 3+ years of experience in a similar field.

Strong time management skills and the ability work well in teams.

Basic understanding of global regulations pertaining to supplier management (particularly US, EU and Japan).

At least 5 years of experience in a GMP regulated industry, preferably biotech, pharmaceutical, or medical device

1 years minimum experience in Quality Assurance, preferably Supplier Quality Experience in working as a part of a cross-functional team.

Confirmed experience in drafting, executing and closure of change controls.

Experience with key elements of the Quality system including deviations, CAPA, and client/regulatory audits.

Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and other stakeholders

Serve as project Quality Manager on medium to large projects, if necessary

Serve as the office Quality Manager, if necessary

Facilitate the implementation of the Operating System Requirements (OSR) in offices for which responsibility is allocated

Job related technical knowledge necessary to complete the job

Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines

Collaborative team contributor with project management and technical writing skills preferred.

The successful candidate will possess the professionalism and technical competency required to represent the department before stakeholders and management.

BS degree in life sciences, engineering, or computer science field or equivalent experience.

Excellent communication skills to support communications with internal and external stakeholders.

The ability to understand business requirements to support planning and leading small and medium size projects applying operational excellence principles.

Support PC (imaging, deployment, and decommissioning) and peripheral configurations.

Experience in Quality Management Systems (QMS)

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

1+ years’ experience in a manufacturing environment

Experience reading, understanding, and interpreting basic engineering drawings and specifications

Experience in a quality job role

Experience in Root Cause Corrective Action (RCCA) and Corrective Action Preventive Action (CAPA)

2+ years of experience in Quality Management Systems (QMS)

2+ years of experience in project management

Reviews proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development.

2+ years of experience data mining, processing, and analysis

2+ years of experience developing presentations for leadership

Analyzes process data, metrics, models and flows to identify root cause of problems.

2+ years of experience in Quality Management Systems (QMS)

2+ years of experience in project management

Reviews proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development.

2+ years of experience data mining, processing, and analysis

2+ years of experience developing presentations for leadership

Analyzes process data, metrics, models and flows to identify root cause of problems.

Outstanding management and communication skills.

Performs all other related duties as directed by management.

Experience in Medical Device industry and knowledge of Good Manufacturing Practices

DHR: Review and approve manufacturing device history records, ensuring compliance with device master record and other quality system requirements.

Manage the Quality Operations team (IQC/MRB/PMC/DHR functions)

Develop and manage departmental budget

LifeCenter offers a competitive benefits package including 401(k) match on the first day of employment.

College degree or equivalent work related experience will be considered

Ability to sit for long periods of time

Can effectively and positively communicate with other team members

Must be able to observe tissue recovery cases in our Tissue Services Department

This position will require the following:

3+ years of experience in Quality Management Systems (QMS).

Experience in a role that required strong analytical, communication and problem-solving skills.

Reviews proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development.

3+ years of experience in data mining, processing, and analysis.

3+ years of experience working with Quality and/or Safety Corrective Action/Preventative Action, Root Cause Corrective Actions.

3+ years of experience working with Problem Solving.

Work in partnership document control and department managers to develop and maintain training requirements for site activities

Position requires critical thinking skills and applied knowledge of industry accepted investigational & Root Cause Analysis techniques

Excellent interpersonal skills with the ability to serve as a liaison with developers, project managers, and customer support.

Facilitate appropriate CAPA owner assignment by working with department managers to ensure resources have been appropriately assigned.

Facilitate appropriate Complaint owner assignment by working with department managers to ensure resources have been appropriately assigned

Maintain established training matrix defining procedural training requirements

3-5 years related work experience

Experience with desktop and server operating systems, including Windows10, Azure and some 2016/19 Server

Extensive application support experience with Microsoft O365, MS Intune, Client Side VPN connection software and Citrix connections

Certifications in CompTia A +, Microsoft Certified Desktop Support Technicians

Deployment of new desktops, workstations, and notebooks as directed by use of Microsoft SCCM deployment tools

Field incoming help requests from end users via both telephone, ticket system, in person and e-mail in a courteous manner