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Director, Plant Quality & Microbiology

Abiomed, Inc.

This is a Contract position in Macon, GA posted May 25, 2022.

Press Tab to Move to Skip to Content Link Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives .

With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical device companies in the world.

We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

Patients First | Innovation | Winning Culture | Heart Recovery Job Responsibilities: Reporting directly to the Senior Director of Global Quality Assurance, the Director of Plant Quality and Microbiology supports the development and production of Abiomed’s products from a quality and compliance perspective.

Additionally, this position will assure all aspects of the Global Quality System are executed from support of Design development through distribution and use of all products.

This role directs multiple Global Quality functions, including but not limited to: Design output, Verification and Validation, Process Validation, Environmental Controls, Product Testing, Material Review Board, Design and Process Changes.

Principle Duties and Responsibilities : Design, develop and execute Quality Manufacturing engineering activities in support of Abiomed’s Product Development and product lifecycle processes, including the Software lifecycle processes including, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, process verification and validation test plans and reports, post-market investigations, follow-up and reporting.

Ensure that FDA and other regulatory knowledge and experience is applied to all Manufacturing and logistics systems including the FDA QSRs (GMP, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard Develop statistically sound sampling plans and perform data analysis Designs and develops the Global Manufacturing and Supplier Quality Engineering programs and supports all manufacturing to help prevent and resolve quality issues Leads and supports MRB activities ensuring appropriate resourcing to minimize value of MRB material and limit part shortages Design, develops and implements the Global supplier quality program including planning and execution of external audits and execution of Supplier corrective actions.

Develop, improve and maintain existing company quality objectives, and track and trend performance Develop and improve existing quality data systems and provide regular quality data on a global basis Designs develops and maintains the Global Risk management programs to ensure the company has risk based quality processes in place in all areas Leads compliance support during FDA and other regulatory compliance inspections Assists departmental management in the execution/implementation of projects, as requested Job Qualifications: BS Degree in a Scientific or Engineering discipline; MS preferred Minimum of 15 years of experience in a GMP-related field within a Med Device or biotechnology manufacturing facility Minimum of 7 years Leading and Managing Quality Manufacturing and associated teams at the company or corporate level Knowledge of global quality systems and regulatory requirements (21 CFR Part 11/210/211/820, ISO 13485, PAL} Subject Matter Expert of GMP, SOPs and quality systems Advanced skills with MS Office applications (Word, Excel, Access) and Adobe Acrobat Ability to communicate and work independently with scientific/technical personnel Excellent interpersonal, verbal and written communication skills are essential Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities Experience with FDA (or Notified Body) inspections Certified for Lead Auditor, Internal/External Audits preferred Ability to quickly grasp technology, medical applications, and applicable regulations/standards Ability to create and effectively communicate regulations/standards Ability to positively influence groups across an organization to embrace a common philosophy in collaboration with various department system owners Ability to manage and execute multiple, critical projects simultaneously Strong ethics to escalate issues in the face of competing priorities Proven record of ability to train and develop staff Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce.

Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

Abiomed maintains a drug-free workplace.