Assistant Supervisor, Quality Assurance 1St Shift

Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Objective:

The objective of this position is to provide support to the Quality Supervisor with day-to-day activities associated with managing production floor Quality personnel and ensuring compliance with all applicable Quality Systems requirements are consistently achieved and product quality is maintained in accordance to established specifications.

Responsibilities and Essential Functions:

• Support with coordinating tasks and duties related to quality control within the organization over multiple operating shifts.
• Maintain product quality by enforcing organizational standards.
• Ensure the results of all inspections are properly documented using good documentation practices in accordance with company policies and procedures.
• Creating and submitting nonconformance reports (NCRs) in the company's electronic data management system (EDMS).
• Support with the review of NCRs in the company's EDMS.
• Ensure nonconforming product is properly segregated or quarantined.
• Ensure products are properly identified and dispositioned in accordance with established procedures.
• Responsible for ensuring DHRs meet established requirements.
• Member of the NCR Response Team. (NRT).
• Act as a QA supervisor fill-in when needed.
• Review/correct and approve employee timecards and time off requests to ensure data is accurately recorded.
• Promote cross functional teamwork.
• Review, investigate, report, and assist in the identification and proper disposition of identified product nonconformances.
• Responsible for identifying proper training requirements and ensuring personnel training is current, in collaboration with Training Leads.
• Responsible for responding to employee concerns, escalating concerns to the appropriate personnel when necessary and following up with employees during this process.
• Foster an environment of open communication with all employees.
• Conduct documented conversations with employees to address absenteeism and offer support when needed.
• Resolve personnel issues by analyzing data, investigating issues, identifying solutions, and recommending actions.
• Enforce plant policies on health, cleanliness, personnel practices, and clothing to ensure integrity of the product.
• Monitor the performance of the quality control staff to ensure alignment with established organizational goals.
• Disseminating quality related information to the rest of the organization when necessary.
• Perform other related duties and responsibilities, as assigned.

Authorities:

• Release of product.
• Stop manufacturing when product does not meet quality specifications.
• Disposition of nonconforming product.
• Stop product shipments.
• Report and escalate safety, quality or other concerns.
• Reject to release the product/lot and escalate any problems to NCR.
• Reject the release of product/lot, if disagreeing with the disposition of an NCR.
• Discipline and terminate employees in accordance with company policy and involvement from the next level up of leadership.

Qualifications:

• 2+ years of relevant Quality Assurance experience in the medical device industry.
• Minimum of 1 year of supervision experience is preferred.

Required skills:

• Understanding of cGMP, ISO13485 and CFR part 820 is highly preferred.
• Good attention to detail and organizational skills.
• Good analytical thinking and problem-solving mindset.
• Ability to work, interact, and communicate effectively with others.
• Effective verbal and written communication skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Must be able to read, write, speak and understand English.

Work Environment:

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.