JOB PURPOSE:

To plan, coordinate, and assist the Quality Manager in the following functions; directs quality control program to ensure continuous production of products consistent with established standards by performing the following duties personally and through subordinates.

KEY ACCOUNTABILITIES:

• Responsible for the oversight, scheduling and daily activities of the Quality Control (QC) Inspectors
• Manage the Quality Control queue, prioritize lots for inspection, including incoming
• Assure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control methods
• Responsible for improving Quality System efficiencies

ESSENTIAL DUTIES:

• Coordinate overtime balanced with queue and company guidance
• Perform employee annual reviews and individual management
• Trains new Quality Control Inspectors on new products or quality processes / cross training
• Responsible for ensuring Quality Control inspection equipment is in conformance to standard requirements
• Assure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control methods
• Creating and validating measurement methods and inspection instructions for various products
• Responsible for diagnosing and resolving technical issues within programs and systems to maintain smooth operations and minimize downtime.
• Prepare quality reports in relation to on-going production and incoming inspection.
• Responsible for the investigation, control and documentation of nonconforming products.
• Be a technical asset in the specifying of new metrology, installing, debugging, and documenting in the use of the devices/test methods. Execute Gage R&R/test method validation with Quality Engineering
• Support quality related processes such as non-conformances, change control, calibration, customer complaints, CAPA (root cause analysis) and equipment qualification and process validation
• Support operations in product non-conformances and feedback for failure mode root cause / process changes
• Quality Engineer support – monitoring Validation runs for compliance to procedure, inspection, gathering/organizing in-process parts and following up on supporting documentation
• Work together with production and operations teams to identify quality issues and implement corrective actions
• Work together with production and operations to drive a Quality culture in manufacturing
• Help support various non-normal/test shipping (i.e. sample parts, etc.)
• Perform job duties in accordance to ISO 13485/9001 including ISO audits
• Performs other duties as required

QUALIFICATIONS:

• Associate Degree or equivalent, or 2-3 years’ related experience and/or training, or equivalent combination of education and experience in inspection in the medical industry
• Has knowledge of commonly-used concepts, practices, and procedures within field
• Ability to problem solve, identify errors and deficiencies and perform research with general guidance
• Strong Computer skills; Microsoft Office (Word, Excel) and Minitab
• Understanding product specifications and interpretation of drawings
• Leadership skills and team player
• Highly organized
• Ability to work in a fast-paced, team environment.
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Ability to apply knowledge to their job function using pre-established guidelines and instructions
• Accuracy, attention to detail, and thoroughness
• Proficient communications skills
• Ability to comprehend and comply with company safety and quality standards
• Ability to follow oral and written instructions
• Familiarity using precision instruments such as micrometers, calipers, dial indicators, Micro Vu (In-Spec software ) and CMM (Zeiss, Calypso software)

Safety Responsibilities

• Ensure that all safety procedures are followed
• Ensure that all equipment safeties are not altered or defeated

Preferred:

• Medical device background

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Pittsfield, MA 01201: Relocate before starting work (Required)

Work Location: In person