Sr. Specialist, Design Quality

Job Summary

In this role, the Senior Quality Specialist is accountable for supporting research and new product development activities within a multi-functional team environment for medical devices.

The Senior Quality Specialist is an integral member of the Quality team to support Design Quality Systems and processes, including Design Control, Change Control, Document Control, training, exception management and improvement opportunities.

The Senior Quality Specialist will actively handle and coordinate tasks in support of product development according to all design control and regulatory requirements and will have supervisory responsibilities for team members at Specialist level.

The Sr. Quality Specialist will also execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support.

Essential Duties and Responsibilities :

• Supervise direct reports, assign workload, set objectives etc. to ensure required goals and deadlines are met.
• Work closely with R&D teams to provide instruction on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
• Partner with and support R&D in product development activities including but not limited to Failure Investigations, CAPAs, Non-Conformance assessments, support for external audits and any audit findings.

Review the quality of work completed with the project team to ensure it meets project standards.

• Support the development of product development QMS procedures and work instructions and training for same.
• Managing DHF documents and control activities (Electronic soft tools version including hard copies).
• Oversee Change Management processes including aspects of document control, change reviews, action item implementation and follow up etc.
• Ability to lead meetings with customers, employees and contractors as necessary to manage changes.
• As the point of contact on assigned projects, performs a variety of highly skilled duties such as assembling, coordinating and managing multidisciplinary technical review teams
• Works with minimal supervision to evaluate gaps and lead projects to close them ensuring escalation of quality related issues appropriately.
• Prepares reports by collecting, analyzing, and summarizing data; makes recommendations
• Provide guidance, mentoring and training to develop direct reports and other team members.
• Other duties as assigned

Basic Qualifications :

• Bachelor Degree in Engineering or Science required
• Minimum 5 years of experience in regulated Quality Assurance / Document / Configuration Control (or a formal education equivalent)
• Ability to work independently, multi-task and thrive in fast-paced environment
• Experience with quality systems such as ISO 13485, 21 CFR 820
• Excellent written and verbal communication skills
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members

Preferred Knowledge, Skills and Abilities :

• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities
• Experience with quality systems such as ISO 14971, 21 CFR 820.30
• Experience with MasterControl, SAP, Share Point, Teamcenter, eCTR
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

Travel Requirements :

5% : Up to 13 business days per year

Physical & Mental Requirements :

Sedentary - exerting up to 10lbs / 4kgs of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.

Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual

Competencies / Authorities

Non-US only where required for certain levels

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