Technical Director, Product Assessor Medical Devices
Remote, REMOTE, United States
Company Description
SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.
Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Job Description
The Medical Devices Technical Director, Business Assurance, North America, develops a profitable and sustainable medical devices business sector within Business Assurance in US and Canada. Ensures the business sector successfully and sustainability grows operational efficiency and profitability. Manage all technical documentation reviews and inquiries for SGS Business Assurance Medical Devices business sectors to ensure the quality of the service delivered meets internal, accreditation, and client requirements. Provide support in the management of client complaints, and internal and external findings. Management Systems Technical support to ALL SGS Business Assurance Management, staff, clients, and other interested parties as required. Work effectively in a team environment with sales, auditors, and client service advisors to provide the highest level of support and responsiveness.
- Conduct medical devices technical file/documentation reviews, and approve calculations of audit time
- Assist in the training/onboarding of new Product Assessors
- Perform observation/witness technical file review assessments as a part of SGS's continuous qualification process.
- Support the development of the systems, processes, and procedures to deliver the service effectively. Proactively identifies opportunities to improve efficiencies.
- Support the development of SGS internal, best practices based on standards to drive and ensure value-added auditing by the product assessor team members.
- Support the recruiting and hiring process to ensure the availability of resources in a timely manner.
- Support developing a comprehensive strategic plan to establish a robust revenue pipeline.
- Coordinates with the Key Account Specialists (KAS) to ensure technical documentation reviews are scheduled in a timely manner, and a high level of customer service is provided to the clients to expand the business.
- Respond to client inquiries on all technical matters regarding SGS-Business Assurance certification /training for standards.
- Maintain competence and credentials by taking additional and/or refresher course(s), as necessary.
- Support the team to ensure that operational KPIs (global and local) are met.
- Support to address client complaints about Technical File Reviewers, investigate the root-cause, and takes corrective action.
- Identifies key growth initiatives and helps drive the initiatives based on target medical devices market sectors and services to expand the business.
- Support determining the resource requirements (technical, commercial, and operational) to establish and grow the business.
- Assist to defines and executing the roadmap to convert strategy into action with key milestones, timelines, and owners to drive business expansion.
- Deliver training and support training material development, conformance with the SGS Global / Local procedures as needed.
- Collaborates daily with the other business sectors and functional areas Directors to ensure effective management of resources: client base, technical resources, and reputation in the marketplace to grow the business aggressively.
- Partners with the Sales and Marketing teams to define and implement go-to-market strategies, and to develop a robust project pipeline across multiple market segments. As required, provide technical advice to sales, marketing, operations, and management.
- Establishes a winning culture that embraces change, risk-taking, and innovative thinking.
- Maintains and develops knowledge and understanding of certification services, standards, regulatory requirements, and client expectations.
- Provides commercial support to the department, including input to tender compilation and project/contract coordination.
- Adheres to internal standards, policies, and procedures.
- Performs other duties as assigned.
Qualifications
Education and Experience
- Bachelor’s degree in Sciences, Engineering, Operations or related discipline
- 10+ years of relevant experience in Medical Devices (Testing, Inspection, Certification),
- 3-5 years of supervisory experience
Knowledge/ Skills/ Abilities
- Language Skills: English - Advanced level of knowledge required, French – any level of proficiency preferred
- Mathematical Skills: Intermediate level of skills preferred
- Reasoning Skills/Abilities: Advanced level required
- Computer Skills: MS Word, Excel, PowerPoint & Outlook - Intermediate user level proficiency required
- Knowledge of market dynamics, including demand growth drivers, new technology, competitor actions, and pricing analysis as they are fundamental requirements for success.
- Knowledge and understanding of current standards and legislation in the Medical Devices industry.
- Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment
- Excellent verbal and written communication, and interpersonal skills
- Strong customer service orientation
- Excellent organizational and time management skills
- Knowledge and understanding of financial indicators, ability to analyze PNL
- Ability to translate strategies into operational and tactical goals and track performance
- Ability to prioritize and execute tasks in a high-pressure environment and make sound decisions in emergency situations
- Ability to motivate teams and lead through influence
- Leadership and coaching skills
Travel
- Travels up to 25% of time. Some travel might be international.
Our Benefits
We care about your total well-being and will support you with the following, subject to your location and role.
- Health: Medical, dental and vision insurance, company-paid life, accident and long-term disability insurance, flexible spending accounts
- Wealth: Competitive pay ($120,000-190,000/year based on experience), bonus opportunity, matching 401(k) with immediate vesting upon enrollment, generous employee referral program
- Happiness:
- Professional Growth: Online training courses, virtual and classroom development experiences, education assistance program
- Work-Life Balance: Paid-time off
- Team Building: Employee engagement and recognition programs, wellness, philanthropic and DE&I initiatives
Additional Information
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
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Dental Disability Insurance Equal opportunity employer Flexible Spending Accounts Medical Time off Vision Vision Insurance
Tasks- Analysis
- Conduct technical file reviews
- Develop medical devices business
- Drive business expansion
- Manage technical documentation
- Support client inquiries
Analysis Audit Auditing Audit Processes Certification Certification Services Client Management Client service Communication Customer service Engineering Excel Interpersonal KPI Management Leadership Management Marketing Medical Devices Operational Efficiency Organizational Process Improvement Sales Strategic planning Team Collaboration Technical Documentation Technical Support Time Management Training Training and Onboarding
Experience5 years
Education TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9