Quality Engineer-QA

Description

Reviews and manages QC samples, issues QC forms, and reviews all results and performs all incoming inspections. This individual will also revise QC sheets, TMs, and lab related SOPs, as needed, and will be responsible for IP testing plans. This role will be self-directed with limited guidance and supervision and will rely on personal experience and judgement to perform primary job responsibilities.

Requirements

• Receive and add samples to QC/Analytics Database. Work with Manufacturing and QC to ensure samples are properly received, logged, and tracked.
• Collect/submit samples for external testing.
• Issue controlled QC forms for testing.
• Full Review of QC records and documentation ensuring compliance with test procedures and GDP on forms and work with supervisor/manager and QE to obtain necessary corrections.
• Completes product release forms & determines final product disposition.
• Initiate NCRs for nonconforming manufacturing material.
• Timely completion of inspections for incoming material received under an IP.
• Enters receiving information on the Incoming Inspection (IP) Database.
• Review of EIQ entries/approval.
• Create/update test plans in EIQ.
• Track/trend samples metrics.
• Review/revise IP/PS documents as required.
• Schedule and/or perform incoming inspections as required.
• Assist Manufacturing personnel with relevant issues.
• Support continuous improvement efforts to the quality management system as assigned.
• Complete in-process quality verifications during shift as required.
• Support and execute CAPA action items as assigned.
• Performs other responsibilities as assigned.

Required Knowledge, Skills and Abilities for Quality Engineer:

• 2 years hands on experience in a quality role in a regulated industry such as medical device or pharmaceutical
• Skilled with Microsoft Office Software (Microsoft Word, Excel, et. al.)
• Good work organizational skills
• Ability to manage time and prioritize
• Excellent communication and interpersonal skills
• Ability to collaboratively interact with people at all levels of the organization
• Good technical writing skills, grammar
• Ability to handle highly confidential business information
• Strong attention to detail
• Ability to think proactively, troubleshoot, investigate and improve systems
• Highly responsible for actions of self and possibly others on the team

Education/Experience Requirements

• Required- Bachelor degree, preferably in a technical discipline.

Preferred Qualifications

• Preferred experience in quality, especially in a regulated environment, inspection experience, lab experience.

Working Conditions at Poly-Med, Inc.

At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.

Physical Requirements:

Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Job Type: Full-time

Pay: $55,000.00 - $72,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Application Question(s):

• Will you now or in the future require employer sponsorship for employment visa status (e.g., H-1B)?

Education:

• Bachelor's (Required)

Experience:

• FDA regulations: 1 year (Preferred)
• nonconformance: 1 year (Required)
• Quality control: 1 year (Required)
• ISO 13485: 1 year (Preferred)
• Document review: 1 year (Required)

Work Location: In person

Salary : $55,000 - $72,000