Job description

We are an ISO 13485 registered manufacturer in northern New Jersey of wire, mechanical cable and assemblies for the medical device industry. We offer innovative manufacturing expertise in fine and ultrafine Stainless Steel, Tungsten, Nitinol and Titanium wire and cable. Our products include tight tolerance-precision cable assemblies, high fatigue life miniature cable assemblies, stainless steel sutures, catheter subassemblies, spinal fixation cables, temporary cardiac pacing leads and catheter components.

Duties and Responsibilities

• Establish and implement process control activities to include capability studies and gage R&R studies.
• Monitor production floor processes for conformance to control plans and customer requirements.
• Coordinate the complaint handling process.
• Coordinate the corrective and preventive action process.
• Assist in the development of and education of measurement techniques for incoming and finished goods inspections.
• Assist in development of inspection processes and documentation.
• Track non-conforming material and lead Material Review Board(MRB) efforts.
• Interface and take the Quality lead role with suppliers and customers.
• Lead complaint investigations on returned product.
• Direct the calibration of measuring and test equipment.
• Assist with personnel training, for subjects specifically related to quality.
• Acts as a lead auditor for internal audits
• Coordinate continuous improvement, workflow and quality improvements.
• Supervise customer and regulatory agency audits.
• Respond to daily quality requirements of the company
• Assist in process/ machine validations.
• Assist in tooling /die approvals.
• Other assignments as requested.

Qualifications

• Requires a multi-disciplined background with a focus on the quality assurance requirements of the medical device industry.
• Must have knowledge of measurement techniques using common tools such as micrometers, calipers, rulers, pin and ring gages.
• Experience with tensile testing a plus.
• Must have working knowledge of all phases of proactive quality engineering.
• Demonstrates experience working in engineering projects in a fast-paced setting.
• Must have good listening skills in addition to excellent verbal and written communication abilities.
• Ability to analyze data and make recommendations in a high stress environment.
• Strong interpersonal skills.
• Ability to work with all levels of personnel from company president to production associates.
• Ability to solve problems and exercise judgement based on the analysis of multiple sources of data

Working conditions

• While performing the duties of this job, the employee will often work near moving mechanical parts and is occasionally exposed to wet and/or humid conditions, ambient air, fumes or airborne particles.

• The noise level in the work environment is usually moderate, but occasionally high, requiring safety equipment to be utilized.

Physical requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Candidate must be able to perform the physical responsibilities of the job utilizing arms, hands, and fingers to perform complex functions of manufacturing parts and performing other duties of the job; e.g., standing, sitting, walking throughout the facility and stairs, bending, squatting, and kneeling, etc.

• Ability to lift items weighing 10-15 lbs.

Job Type: Full-time

Benefits:

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

Schedule:

• 8 hour shift
• Monday to Friday
• Weekend availability

COVID-19 considerations:
Wearing a mask is optional.

Ability to commute/relocate:

• Ho-Ho-Kus, NJ 07423: Reliably commute or planning to relocate before starting work (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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