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Quality Engineering Manager – North Shore MA

Manager of Quality Engineering will be responsible for supporting the development and manufacturing of new and modified products, establishment of quality systems for the effective control of these products and resolution of quality and manufacturing problems which arise during manufacturing.

Primary Duties and Responsibilities:

  • Evaluation and approval of new product designs, specifications and product test procedures.
  • Support product development, including design control and risk management
  • Providing the smooth transition of new products to manufacturing through the continuous review of all quality systems, inspection data and product yields.
  • Support failure investigation process to identify root cause of product, process, and system non-conformances in order to drive continuous improvement as well as corrective and preventive actions.
  • Mentoring, coaching and development of AQE personnel
  • Designing and executing statistical engineering experiments to compare design alternatives, compare proposed product with competitive products and evaluate performance.
  • Ensure Quality process throughout  new product development

Job Qualifications:

  • Masters degree in engineering, 8+ years in medical device with 3 years in quality management or Bachelors degree in engineering and 10+ years of medical device with 3 in quality management.
  • Must have ASQ certifications in CQE or CSSBB.
  • SAP experience (Quality Module), and Managing international teams is a plus

To apply for this position please see the link “US Openings” in the Right Column.

Sr. Clinical Research Manager – Northern MA

The Sr Clinical Research Manager is responsible for the coordination/management of all clinical trials.

Responsibilities:

  • Serve as primary point of contact for assigned clinical studies.
  • Develop and implement daily clinical research operations to meet company goals and objectives.
  • Work with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice.
  • Manage Clinical Project Managers and/or Clinical Research Associates.
  • Ensure that Clinical Operations department works closely with Medical Affairs, R&D, Manufacturing, Sales, Marketing, Regulatory Affairs in US, as well as overseas Clinical Groups to drive clinical initiatives.
  • Participate in vendor selection, and establish plans for data processing and data review with vendors.
  • Assist in the preparation of clinical summaries for IDEs, 510(k) s, PMAs and related regulatory filings.
  • Oversee internal and external audits.
  • Oversee SOP review for the department and employee training.
  • Maintain knowledge of competitive technologies and be a subject matter expert in all company products.

Qualifications

·Bachelor’s degree in sciences or related medical/scientific field with a minimum 10 years clinical research experience

·Experienced in managing programs with Class III devices.

To apply for this position please see the link “US Openings” in the Right Column.

Sr. / Product Manager – Northern MA – Biotech

As Product Manager, you will guide a team that is charged with a product line contribution as a business unit. This extends from increasing the profitability of existing products to developing new products for the company.

ESSENTIAL FUNCTIONS:
Managing the entire product line life cycle from strategic planning to tactical activities
Create and execute market research plans to identify customer needs and market requirements.
Participate in market research related to product launch planning, branding and segmentation, positioning, market acceptance, etc.
Become a subject matter expert with competing target enrichment methods as well as technological alternatives
Establish marketing plans, pricing strategies, and product positioning
Establish and develop key internal and external relationships, including cross functional teams, field teams and thought leader
Work with the Market Communications Manager on promotional and launch campaign
Responsible for reviewing product data to ensure that the field force is kept up to date on new developments regarding the companies or competitors’ products

REQUIREMENTS:
• BA or MS degree
• Minimum 5 years’ experience in product management or related experience in the Life Science market
• Demonstrated success defining and launching life science products; diagnostic testing preferred

To apply for this position please see the link “US Openings” in the Right Column.

“LSS Team News” August 2015

The Life Science Staffing Team would like to congratulate our client in Northern Massachusetts in the Medical Device Industry and their new Manufacturing Project Lead !!

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“I haven’t failed. I’ve just found 10,000 ways that won’t work.” - Thomas Edison