External Wholesaler jobs

Spencer Gregory Hale

Your responsibilities include:

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the BSC quality system requirements as well as supporting any requirements from the supplier’s Quality system.
• Investigates and solves non-conformances due to product realization, product performance, incoming inspection, audit findings, etc.
• Supports Design Quality Assurance with post market surveillance, trending Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
• Investigates complaints, defines complaint management processes and manages NCEPs at OEM suppliers, CM suppliers and other categories of suppliers where the issue is manufacturing-related.
• Supports Supplier Change Impact Assessments for process changes at suppliers.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Creates, defines and manages Inspection Plans for finished devices in BSC Distribution Centers
• Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.
• Leads and/or supports continuous improvement opportunities to drive efficiency and effectivity at BSC points of use.

New Product Development:

• Execute SFMD Plan deliverables for integration and/or onboarding of supplier and related products into BSC’s Quality System.
• Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Lead and support initial on-boarding assessments, new manufacturing locations and supplier’s approved status

Quality System Champion:

• Supports Material Controls external regulatory body audits requests as required.
• Leads or supports Material Controls internal audit efforts.
• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Identifies and advises management on potential improvements to quality systems and processes in the company.
• Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you:
Minimal Qualifications:

• BS degree in engineering or technical field with minimum of 5+ years of relevant experience.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, SCAR.
• Ability to work independently; organized and self-driven.
• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%.

Preferred Qualifications:

• 3+ years of medical device engineering experience preferred.
• Medical Device Industry experience
• Problem Solving and Project Management experience
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.

Maximum Salary: $ 144400

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Your Responsibilities Include:

• Interface effectively with key stakeholders internally and externally (Divisions, Suppliers, and commercial sourcing teams) to deliver key strategies in terms of Quality, Cost and Service improvement. Develop key relationships with Supplier leadership to influence effective execution and achievement of key deliverables and results.
• Responsible for leading and developing a best-in-class supplier engineering team that is proficient in the use of lean, 6sigma and engineering first principal methodologies.
• Lead supplier engineers in the development, implementation, and monitoring of plans to support divisional objectives in onboarding new suppliers, introducing New Products through the full network of SFMD suppliers and ensuring that change management is resourced and is aligned with policy.
• Ensure that suppliers are educated on BSC Change management Processes and work with suppliers to assess any new risk that changes may introduce.
• Ensure that supply chain objectives are achieved through enabling and improving our key business processes. Supplier performance Reviews, Finished Goods Material Risk Mitigation, and execution of materials VIP.
• Acts as resources for department engineers on technical issues. Drive the use of structured problem solving and statistical techniques. Provide immediate assistance for supplied material failures and support long-term efforts to eliminate causes of failures.
• Understand FDA, ISO and corporate requirements pertaining to qualification of supplied material.
• Manage and support the identification and development of new or existing supply sources with the purchasing team. Collaborate with other BSC cross functional resources in identifying insourcing / outsourcing opportunities.
• Proactively identify and drive Value Improvement Projects (VIPs) with suppliers at all Tiers in the supply chain.
• Collaborate with vendors to improve process capability and stability through introduction and sustaining new product projects.
• Develop negotiation strategies with the procurement team to maximize value add initiatives.
• Play a lead role in the development of commodity strategies in conjunction with commercial sourcing and supplier quality team members.
• Develop and execute department budgets – headcount, overhead/project spend and capital planning/control.
• Ability to travel domestically and internationally is required.

Required Qualifications:

• Bachelor’s degree in engineering/Technical from ABET accredited institution.
• 7+ years professional engineering, technical and lean manufacturing experience.
• Experience leading cross-functional and matrixed organizations with ability to influence and drive performance.
• Experience managing ambiguous situations with strong change management and conflict resolution skills.
• Demonstrated People and Team leadership.
• Ability to travel up to 25% of the time (Including International). Travel typically does not occur over weekends.

Preferred Qualifications:

• Experience in Medical device or a highly regulated industry.
• Experience with suppliers and finished devices.
• Working knowledge of quality system requirements & regulations

Maximum Salary: $ 197000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.