Description: ·          Provide support in the establishment and maintenance of processes pertaining to regulatory compliance and quality systems to ensure regulatory requirements for compliance.   EDUCATION / EXPERIENCE REQUIRED: ·          BS/BSN ( Science or Engineering preferred) OR ·          3-5 years of related experience and/or training in quality role ·          3-5 years experience in working in an medical device or other regulated industry ·          Working Knowledge of 21 CFR Part 820, ISO 13485, and MDD/IVDD requirements. ·          Experience supporting external audit such as FDA, Notified Body, or customer audits. ·          Possess the ability to work autonomous on specific compliance or quality systems projects with accelerated timelines and base business activities. ·          Critical thinker, detailed oriented, while overseeing multiple tasks for several projects or base business deliverables. ·          Excellence computer (e.g., PowerPoint, WORD, Excel), communication, and written skills. ·          Experience providing project support to senior and executive management.   KEY JOB RESPONSIBILITIES: ·          The Compliance & Quality Systems Specialist will collaborate with business partners to ensure compliance to all regulatory and standard requirements. Specific areas of focus will be: ·          Management Review: Monitor all sources of quality data to ensure that appropriate review and escalation through risk management system. Lead the QS management review process in the compilation, final approval, and presentation of T1 and T2 management review quality data. Will be responsible for coordinating cross functional teams and QS metrics reporting to ensure that compliance with defined procedures. ·          Field Action: Provide support/backup to the Compliance Manager on all Field Action activities including ASP correspondence to the FDA. ·          External and SI/Customer Audit Support: Manage and coordinate all external and SI audits. Will serve as audit and Front Room management. ·          Quality Review Boards (QRB): Identify and facilitate issues based on metrics reported to ensure that product issues are appropriately escalated to QRB in efficient and timely manner ·          Special Projects and Base Business: Under general supervision establish and maintain quality system and compliance program, procedures and controls to ensure that the performance and quality of product conforms to the established processes and procedures. Work product quality engineering, operations engineering and research & development to review and ensure adherence to established procedures. Provide compliance and quality system support of special project s directed by the Compliance & Quality Systems Director, Compliance Manager, or Quality Systems Manager. Additional base business support will include activities identified by the Compliance Manager. ·          Quality System Back-up Support: Will provide back-up support to the Quality Systems department as appropriate.   PHYSICAL DEMANDS: Walking, standing, and sitting for extended periods.   WORK ENVIRONMENT: Office environment and (where appropriate) travel   SUPERVISORY RESPONSIBILITIES: This position does not have direct reports.     SAFETY: ·          All employees have a duty to care for their safety and for the safety of others whom may be affected by their acts or omissions at work. Therefore it is the duty of every employee to:   ·          Respect and apply safety rules and procedures at all times ·          Use personal protective equipment and safety devices as required ·          Promote industrial hygiene and safety matters ·          Report incidents and damages to management whether injuries are involved or not ·          Participate in incident investigation ·          Report hazards to management ·          Ensure a high standard of housekeeping in the work area ·          Be a safety role-model to all employees ·          Make suggestions to improve safety at the workplace ·          Actively participate in department safety committee   COMPLIANCE: ·          All employees have a duty to comply with applicable laws, regulations, standards, J&J policies and ASP policies and procedures. Examples of required areas of compliance include but are not limited to: ·          Quality Systems (including Product Complaints, Corrective and Preventive Actions (CAPA), Internal Audits, Good Manufacturing Procedures (GMP), and Good Documentation Practices (GDP)) ·          Sarbanes-Oxley (SOX) ·          Health Care Compliance (HCC) ·          Government Contract Compliance (GCC) ·          Environmental Regulations ·          Records Management ·          Johnson & Johnson Business Conduct and Employee Policies   Please Note: Submit your resume through this posting. Please Do Not Call, we will call you. ======================================================== Pioneer Data Systems, Inc. an "Inc 500" and "NJ Technology Fast 50" company, is a preferred provider to Fortune 500 Clients nationwide. We distinguish ourselves by providing outstanding service to our clients using emerging and innovative technologies. PDS offers excellent compensation, benefits and   constant flow of new challenges to its consultants. We understand that every professional has different needs, so we will work with you to determine a suitable benefit package, which includes;   group medical plan (Section 125), 401K Plan, etc. We are an E-Verify Employer. For further information, please visit us at   www.pioneerdata.com