Long Term Contract with potential to convert to perm.Provide Quality System implementation support for medical devices, including the device constituent part of combination products. This position will interact with internal cross functional teams working with all levels of colleagues in the organization. Activities will include creation or enhancement of Quality System related, policies, procedures, and processes to ensure compliance with Medical Device (ISO 13485, 21CFR Part 820, MEDDEV 2.12-1) and Combination Product regulations (21CFR part 4). The primary purpose of this position is to provide subject matter expertise in support of successful adaptation of the current Quality Management System to be in compliance with Medical Device/ Combination Product regulatory requirements. This individual will be expected to apply his/her knowledge of Quality System requirements and current regulatory expectations as they relate to product development and commercialization of Medical devices/ Combination Products to positively influence commercial and new product launches to ensure they are developed and manufactured in accordance with regulatory, company, and patient requirements.Principal ResponsibilitiesLead or support gap assessments of the current Quality System elements and mitigation against the requirements of applicable medical device and combination product regulatory standards.Support the development of an efficient, fit for purpose and effective Quality Management System that meets global device requirements, in areas such as CAPA, Complaint Management, Change Control, Internal Auditing, Risk Management, and Supplier Management.Provide Medical Device/ Combination Product regulatory guidance and/ or training to personnel as needed to ensure procedures and processes are implemented effectively.Support the integration of the specific medical device quality system requirements with the current pharmaceutical quality system.Support development of submissions with global regulatory agencies leading to approvals and SkillsExperience10+ years quality management / regulatory leadership experience in medical devices, experience in pharmaceuticals and combination products is highly desirable.Experience in software driven medical devices / capital equipment. Extensive knowledge of FDA, GMP and ISO standards and regulations.Combination product and device delivery system experienceDemonstrated ability in decision making, problem solving and project management. Collaborate, negotiate, influence and lead in a matrix organizationExcellent communication and interpersonal skillsProven record in demonstrating agilityFlexibility to travel in support of the roleKnowledge of process development and quality systems with a strong business and technical acumen would be an advantage.Armstrong Consulting Group helps companies in diverse industries by providing contract, contract to hire and permanent staffing solutions in all areas of Information Technology, Engineering, Pharmaceutical and Administration.We attract, recruit and deliver the highest quality professionals best suited for organizations by fully understanding the requirements and culture of our customers. As a highly respected and professionally managed team with over 25 years experience in the staffing industry, we foster long term relationships with clients and candidates as they successfully grow their businesses and careers.