Job description

I. Manage the day-to-day quality control, quality engineering and

document control activities for in-house production and contract

manufacturing of all products. Responsible for planning activities

concerned with application and maintenance of quality standards

and development of procedures for qualification of manufacturing

processes, materials and products. Resolve quality problems and

improve areas of high quality costs. Monitor and report on facility

quality systems and programs. Represent quality interests and

concerns on project teams.

II. Principal Duties and Responsibilities include the following: (Other

duties may be assigned)

 Assure that the Quality System is in compliance with applicable

standards and regulations, including cGMP, ISO 13485:2003, and

the Medical Devices Directive.

 Perform facility internal and external audits and oversee Corrective

Action program. Responsible to recommend corrective action to the

Quality System based upon internal or external quality reports.

 Responsible for the document change control process.

 Interface with R&D to ensure that products are designed for patient

safety in terms of FMEA, hazard analysis, Quality System

compliance and manufacturability.

 Develop, refine and document quality control test and inspection

procedures.

 Support activities related to product verification and validation

processes.

 Support implementation of sterility and biological test/validation

requirements.

 Coordinate and assist in the qualification of internal and external

manufacturing operations.

 Responsible for investigation of product complaints.

 Perform other quality engineering duties when requested.

III. Supervisory Responsibilities: List number and titles of positions directly

supervised None.

IV. Qualification Requirements:

Bachelor’s degree in scientific/engineering or relevant discipline

 Minimum of three to five years of medical industry experience in

quality function.

 Thorough understanding of FDA, EU (MDD/MDR) and applicable

regional and/or local regulations, the MDD/MDR and requirements

pertaining to CE marking.

 Thorough knowledge of product development process and design

control.

Knowledge/Skill: Identify specific knowledge and /or minimum skill.

 Technical background, scientific judgment, exhibit initiative.

 Knowledgeable in application of quality principles and industry

guidelines for quality systems.

 Strong communication skills.

 Ability to conduct an audit and to undergo audit.

 Excellent interpersonal skills and ability to motivate others who are

not in the department.

 Computer literacy, proficiency in MS Office, Excel, PowerPoint,

etc.

 Excellent organizational skills and attention to detail.

 ASQ certification (i.e., CQA, CQE) a plus.

V. Working Conditions

Identify important physical job demands (i.e. lifting, bending, etc.).

Duties of this position are generally performed in good working

conditions. Occasional exposure to elements such as noise, dust,

chemicals, operating machinery, temperature extremes, etc.

Job Type: Full-time

Pay: Up to $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Mansfield, MA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• medical device industry: 3 years (Preferred)
• quality engineering: 3 years (Preferred)

Work Location: In person

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