Senior Operations Director
Human sized company
About Our Client
Our client is a human sized company active in the medical devices development and commercialization globally.
- Anticipate industrial, quality and regulatory needs for future years.
- Collaborate with executive-level management in the development of performance goals and long term operational plans.
- Plan, monitor, and analyze key metrics for the performance of the operations to maximize motivation, efficiency and productivity.
- Analyze current operational processes and performance, recommending solutions and guidelines for improvement when necessary.
- Plan, review and adjust operational budgets to promote profitability.
- Setup and manage Supply Chain, Quality Assurance, and Regulatory Affairs by the mean of dedicated resources.
- Oversee, in the departments above, Job Description, appropriate hiring, workload, employee training and certification programs.
Quality & Regulatory
- Strengthens compliance and establishes required procedures (interprets, clarifies, explains and
applies policies and procedures, business practices, federal or state laws and regulations, etc)
- Ensure promotion of awareness of applicable requirements in company.
- Lead and promote the awareness of the Quality Management System requirements.
- Ensure that Supply Chain organization is calibrated to deliver compliant devices according to the Demand forecasts/Sales plan communicated by Sales & Marketing department.
- Demand forecasts/Sales plan communicated by Sales & Marketing department.
- Ensure process improvements and new products transfer by working closely with suppliers, CME,OEM, R&D and Quality departments.
- Identify different Supply Chain options in order to manage COGS (Cost of Goods Sold) at competitive level provided stage of the business and design constraints.
- Managing relationships/agreements with external partners/vendors.
The job holder is in charge of:
- Operational budget control
- Operational Processes
- Safety in the workplace
- Effectiveness of the QMS thru the internal audit process, CAPA process and management review.
- Availability of compliant devices for sales demand
- Compliance with applicable laws, regulations, and/or agency rules, standards, essential requirements and guidelines
- Regulatory directive 93/42/CE, MDR 2017/745, 21CFR820, SOR98/282, RDC16/2013,TG(MD)R2002
- ISO Standards 13485:2016 and 14971:2019
- Any other regulations that might be needed in other countries where The Organization plans to sell products.
- Any Quality responsibilities as described in Quality Documentation of The Organization
- Authority & Delegation
The Successful Applicant
- Proven experience (10 years minimum expected) as COO or equivalent position within international environment in Medical Technologies.
- Superior knowledge of Medical Devices industry regulations and standards (regulatory directive but not limited to 93/42/CE, MDR 2017/745, 21CFR820, SRO98/282, RDC16/2013, TG(MD)R2022, MHLW MO169, ISO Standards 13485:2016 and 14971:2019
- Track record in MDSAP Audit will be a plus
- Superior knowledge of diverse operational functions and principles, including supply chain, and demonstrated success innovative solutions to increase profitability.
- Working knowledge of data analysis and performance / operation metrics.
- Familiarity with MS Office and business software (e.g ERP).
- Experience of CEGID will be a plus.
- Scientific/ Engineering education (MSc as a minimum).
- Fluent in English.
- Personal attributes: Outstanding negotiation skills, excellent leadership and organizational abilities, excellent interpersonal, written and oral communication skills - ethics.
What's on Offer
Great opportunity to join an entrepreneurial and very dynamic environment.
PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.