REMOTE SR QUALITY SYSTEMS SPEC

Remote Sr Quality Systems Spec Location: Remote, CT Category: Quality and Compliance Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site Apply For This Position Job Description What are the top 3 things you are looking for in a candidates experience: Work independently under limited supervision to manage changes through document control systems. Practical knowledge of project or program management. Make improvements of processes, systems or products to enhance performance of the job area. Requires knowledge and experience working with medical devices regulations and industry guidances and standards. Responsibilities may include the following and other duties may be assigned: Assists with the development and maintenance of quality programs, systems, processes and procedures, including managing changes through document control systems, to ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.Initiates and supports processing of changes in MAP Agile.Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to ensure compliance.Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.Coordinates legal requests in support of government investigations or litigations.Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally. This work will include facilitating regular meetings and communications with appropriate communities within the organization. Required Knowledge And Experience Requires knowledge and experience working with medical devices regulations and industry guidances and standards.Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.May have practical knowledge of project management.Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Differentiating Factors Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others’ work product . Equal Opportunity Employer We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements. Fraud Alert Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.