Scientific Products, an ATS Life Sciences Company is searching for a Global Quality Director to our team!

　　The Global Quality Director position will report to the VP of Operations and will be responsible for leading and driving quality improvement initiatives across the organization, maintaining and enhancing the quality management system, and working with the manufacturing plants to comply with all applicable regulatory and compliance requirements, including "Current Good Manufacturing practice for Finished Pharmaceuticals".

　　The ideal candidate will have extensive experience with capital/process equipment manufacturing, and all of the associated regulatory, compliance, and GMP quality processes for an ISO 9001:2015 quality management system. This leader's primary responsibility will be leading the quality engineering and quality control functions, while at the same time working across the organization to improve the quality management system, manage the corrective action process, and non-conformance process. This leader will also coordinate with the filed service and final test teams to evaluate and enhance the overall quality of SP's Equipment.

　　Essential Duties and Responsibilities

　　This role exists to ensure SP Industries delivers the required level of quality and performance to our customers which are both the end users of our products or services and our shareholder owners. This role is predominantly a key contributor role and so the successful candidate will need to work in partnership with all departments, influencing the teams at multiple levels in the organization, to facilitate overall regulatory compliance. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

　　QMS ISO9001:2015 compliance

　　Manage the QMS ISO9001:2015 compliance process across the SP businesses, with a long term aim to integrate all sites under 1 accreditation certificate.Interprets and implements quality assurance standards appropriate for our businessCollect and compile information to provide reporting on all QMS inspection results, vendor scorecard data and communicate to organization members, from ELT (Executive Leadership Team) across the organization.Lead the internal audits process on products and / or processes and procedures and drive corrective actions with the departmental teams as needed.Identify and implement best practices to optimize products (with local teams) and process / procedure quality to improve efficiency to ensure customers receive services to established specifications and / or to exceed their expectations.Drive continuous improvement of our quality management system.Works with HR to ensure new team members are familiar with our QMS and our quality expectations.

　　Worldwide legislation & regulatory compliance

　　Manage and maintain compliance with regulatory bodies.Provide regulatory affairs support to design teams and the document control/change request systemEnsures training for current company associates is up to date and trains new associates.Prepare Technical File, CE Mark, and other related regulatory filingsAssist with preparation of U.S. regulatory submissions, Design Dossiers for European Union submissions, technical files, reviewing design control documents, and being an active member of design teams representing the regulatory affairs responsibilityDevelop, document, and implement regulatory strategies for new technologies and product modifications to include all applicable regulatory requirementsMaintain and updates guidelines relating to international and domestic regulations for finished products and raw materials: ROHS / REACH / CM / F-Gas / ASME / PED etc.Provides regulatory documents in compliance with customer and country-specific requirements.Establish and maintain regulatory standards, procedures and controls.

　　Collaborate with Engineering and Project Management to create Quality and Project Plans (QPP)

　　Create and participate in project risk analysis

　　Monitor, participate and approve stage gate reviews as defined in the QPP

　　Monitor and approve test progress and tests results as defined in project test plans

　　Other duties as required to create a world class company

　　Qualifications: Education, Experience, Skills, and Certifications

　　Expert working knowledge of ASTM E-2500, Standard Guide for Specification, Design and Verification of Biopharmaceutical Manufacturing Systems and Equipment.Expert working knowledge of US Food & Drug Administration-code of federal Regulations, Title 21, part 211,"Current Good Manufacturing practice For Finished Pharmaceuticals"Expert working knowledge of US Food & Drug Administration-code of federal Regulations, Title 21, part 210,"Current Good Manufacturing practice in Manufacturing, Processing, Packaging, or Holding of Drugs"Expert working knowledge of EudraLex Volume 4 - "Guidelines for good manufacturing practices for medicinal products for human and veterinary use" and applicable appendices.Bachelor's Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage7-10 years of experience in a Biopharma process equipment, Medical Device, , or regulated manufacturing environmentMinimum of 7 years of experience and a proven track record of successfully creating and managing a highly talented, engaged and high-performing teamDemonstrated leadership ability to develop and implement organization and functional strategies; Initiates, sponsors and implements change with a demonstrated track record in QA Improvement.Expert working knowledge of regulatory requirements, standards and regulations, with experience managing ISO 9001 or ISO 13485 quality auditsWorking knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma toolsMust be able to work in a team & individual environments, interacting effectively at all levels, and across all functions with ability to develop organizational relationship and build trustDemonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency at all timesThe candidate must be highly organized, disciplined, and be able to demonstrate their ability to meet deadlinesPrevious experience in regulatory, compliance, quality processes requiredStrong analytics and structured problem solving experienceThorough understanding of ISO standards and conformanceStrong project management skillsAbility to interact effectively with internal and external customersExcellent people skills with the ability to evaluate, coach, and motivate employeesProficient in the use of MS Office, Outlook, Word, Excel and PowerPoint applicationsKnowledge of Agile methodologies

　　Language Skills

　　Excellent verbal and written communi

　　Reasoning Ability

　　Able to understand and review technical documentation, including project plans, test procedures, and design documents

　　Certificates, Licenses, Registrations

　　ASQ Certification preferred (CQM, CQE, CQA) The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

　　Work Environment

　　Work is normally performed in both the office and the shop.The office environment is an interior office with air conditioning.The shop contains mobile equipment, machinery, and high voltages.The shop noise level is variable and may require hearing protection in some areas.The shop is heated when required but many areas are not air conditioned.Some shop processes use high voltage arcs or concentrated magnetic fields.

　　Why Scientific Products?

　　The three parallelograms in our logo reflect our core company values: People, Process, and Performance. As part of ATS, Scientific Products leverages the ATS Business Model (ABM) to train, develop, engage, empower, and energize our people to make impactful changes in the organization. Our relentless focus on people is what continues to set us apart as a great place to build a career.

　　• We provide a wide range of innovative and high-quality scientific products that improve people's lives

　　• We offer a robust health and welfare benefits package that includes Life, Health, Dental, Vision

　　• We offer 401(K) including company match, Paid Time Off annually + Paid Holidays

　　• You will enjoy career Advancement Opportunities and Tuition Assistance to help you achieve your goals and continue your career growth

　　EEO and Affirmative Action Statement:

　　SP is an Equal Opportunity Employer, dedicated to a policy of non-discrimination in employment on any basis and takes affirmative action to ensure equal employment opportunities. It is our policy to provide our employees and applicants with equal employment opportunities in accordance with applicable laws and not to discriminate on the basis of race, color, religion, ancestry, national origin, age, marital status, sex, gender identification, sexual orientation, genetic information, political belief, pregnancy, citizenship, handicap or disability, status as a veteran or member of the U.S. military, or any other characteristic protected by applicable federal, state, or local laws. SP's Affirmative Action Plan is available through the HR Department and may be accessed during normal business hours.

　　Pay Transparency Nondiscrimination Provision:

　　SP will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. #INDSP